NuVasive ERC 3P User manual

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 1of 45
External Remote Controller ERC 3P
Patient Manual
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 2of 45
To Physicians: Reference the External Remote Controller ERC 3P Operator’s Manual and
respective Precice Instructions for Use for clinical set-up and information for healthcare
practitioners. Provide a copy of this External Remote Controller ERC 3P Patient Manual to each
patient and review it with them before treatment. Make sure to record the patient’s prescription
on the next page.
To Patients: Read this entire booklet before you use the ERC 3P. Refer to this booklet at any
time during your treatment. You can also talk to your doctor about any questions you have.
GENERAL CONTACT INFO:
101 ENTERPRISE,SUITE 100 |ALISO VIEJO,CA 92656
PHONE:[phone] |FAX:[phone]

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 3of 45
TABLE OF CONTENTS
1) My Prescription.....................................................................................................................................................4
2) SYMBOL DEFINITIONS....................................................................................................................................5
3) DEFINITIONS AND GLOSSARY .....................................................................................................................8
4) INDICATIONS FOR USE: Why is Precice Used? ............................................................................................9
5) CONTRAINDICATIONS: Who cannot use the Precice System? .................................................................10
6) WARNINGS AND CAUTIONS: What must you do to avoid serious harm? ..............................................13
7) RISKS: What are the risks of this procedure? ................................................................................................18
8) PRODUCT DESCRIPTION: About your Precice Implant and ERC...........................................................19
9) SMART FEATURES..........................................................................................................................................22
10) ABOUT THE ERC .............................................................................................................................................23
11) How to use the ERC............................................................................................................................................25
12) INSPECTING, CLEANING, STORAGE AND OTHER INFORMATION.................................................36
13) MORE ABOUT YOUR CONDITION .............................................................................................................37
14) TROUBLESHOOTING .....................................................................................................................................38
15) ERROR CODES .................................................................................................................................................39
16) SPECIFICATIONS ............................................................................................................................................41

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 4of 45
1) MY PRESCRIPTION
Date
Implant
Location
Distance Per Session
(example: 0.25mm)
Sessions Per Day
(example: 4 times/day)
Daily Total
(example: 1.00mm)
Where to place the ERC during each session:
(Circle the general location – there will be a specific mark on your leg)
RIGHT LEG
LEFT LEG
IMPLANT #1
£Right Leg
£Left Leg
£Tibia
£Femur
IMPLANT #2
£Only One Implant
£Right Leg
£Left Leg
£Tibia
£Femur
Special Notes (example: always use crutches):
____________________________________________________
Need help? Call:
My Provider:
Phone:
My Doctor:
Phone:
Femur
Femur
Tibia

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Model: ERC 3P
LC0216-H-2/2022 Page 5of 45
2) SYMBOL DEFINITIONS
For Symbols Glossary, please refer to https://www.nuvasive.com/eifu/symbols-glossary
For Symbols specific to the ERC 3P reference the table below.
Symbol
Definition
IPX1
The ERC shall experience no harmful effects from
dripping water
Initialization Screen
This screen is used to instruct the user to initialize the ERC
3P prior to therapy when the implant detection sensors are
turned on When this screen is displayed, the ERC 3P
should be placed back into its case with power still turned
on. Metal should not be in the vicinity of the ERC 3P. The
Control Button is then pressed and the ERC 3P will rotate
the magnets in a forward and reverse direction. The ERC
3P is then ready for or continued therapy.
Go Back key: This is a touch screen key that provides a
method to go back to a previous screen or software state
when it is displayed and pressed by the user.
Continue Key: This is a touch screen key that provides a
method to advance to the next screen or software state
when it is displayed and pressed by the user.
Reset Value Key: When displayed, this touch screen key
next to a value displayed allows the user to reset it when it
is pressed.
Clinical Key: This touchscreen key provides a method for
a clinician to access software modes limited to non-
patients. Accessing these modes requires a passcode.
Control Button, Blinking Green: An external button is
used by users to begin therapy, accept parameters entered,
or advance to the software screen.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 6of 45
Control Button, Solid Red: An external button is used by
users to stop therapy at any time.
Alignment Line: This line symbol labeled on the ERC 3P
identifies the center of the ERC 3P magnet lengths. It can
be used as method to align ERC magnets to implant
magnets based on the lines or sutures located on the
patient’s limb.
Alignment Area: This symbol is located within the
Alignment Window over the center bar. It is used to
identify that the location where the implant magnet must
align with the ERC within the Alignment Window.
ERC 3P Position Orientation LEFT with ARROW: This
symbol and labeling indicates the orientation of the ERC
3P relative to the patient. The patient should be able to
view this symbol with arrows pointed toward their feet.
LEFT indicates the left side of the unit is positioned to the
left side of the patient.
ERC 3P Position Orientation RIGHT with ARROW: This
symbol and labeling indicates the orientation of the ERC
3P relative to the patient. The patient should be able to
view this symbol with arrows pointed toward their feet.
RIGHT indicates the right side of the unit is positioned to
the right side of the patient.
Uncoupled Implant Detection: This symbol displayed
indicates that the ERC 3P does not detect implant magnets
or their rotation.
Reposition and realign, then press Go until icon
indicates ERC is connected to the implant.
Coupled Implant Detection: This symbol displayed
indicates the ERC 3P has detected the implant magnet and

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 7of 45
it is properly rotating.
Stalled Implant Detection: This symbol displayed indicates
that the ERC 3P has detected the implant magnet and that
it is unable to complete a full rotation. This is due to
excessive linear force against the implant or weak magnetic
coupling between the ERC and implant magnets.
Realign the ERC using the mark on your skin and the
locating window, alignment lines on the ERC. If the error
code continues to display, please contact NuVasive
Specialized Orthopedics, Inc.
Initialization Button: This touchscreen button is displayed
in Operating Room Mode when the unit is idle. Pressing it
allows the user to begin the Initialization process for the
ERC 3P at a time when it’s convenient.
Initialization Marker: Located on the Progress Bar in
Operating Room Mode, they are used to indicate a point
when therapy will be paused for required initialization.
Green markers to the far right of the progress bar indicate
that no initialization is required during the session.
Anatomic Instruction Screen
The patient’s specific left or right side femur or tibia will
be highlighted on the screen to identify the exact limb with
the PRECICE implant. There are four possible locations
for the implant, only one will be shown with a solid purple
line.
System Error Screen
This screen will appear on the control panel when there
has been an error with the operation of the ERC 3P.
In this figure “123” is given as an example. The screen
may have a different code shown.

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Model: ERC 3P
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3) DEFINITIONS AND GLOSSARY
This section gives definitions to words that are used in this guide.
Active Medical Device: The term "active" means any medical device that needs a power supply.
Power can be supplied by any means including electricity, battery, or gas. Examples of active
devices include ventilators, pacemakers, and patient monitoring devices.
Actuator: The part of the Precice device that can change in length when activated.
Contraindication: Any condition that renders using the Precice system undesirable or
inadvisable.
Coupling: Pairing of the ERC to the Precice device magnetically.
Distract: Distract means to extend or lengthen. The Precice system is used to distract bones.
Retract: Retract means to shorten. The Precice system is used to distract or retract bones.
Electronic Device: This refers to any device that has a power cord that is plugged in for
electrical power or is battery operated. Examples include computers and cell phones.
ERC: ERC refers to External Remote Controller. The ERC is used to adjust the Precice device
that is in your leg from outside of your body. The ERC system consists of the ERC, and Power
Cord.
Femur: The femur is the thigh bone in the leg. It is the largest bone of the body and is situated
between the hip and the knee.
Tibia: The tibia (or shinbone) is the large leg bone between the knee and ankle.
Humerus: The humerus is the upper arm bone. This is the bone located between the
shoulder and elbow joint.
Implant: An implant is a device that is inserted into the body for a period of time.
Intramedullary: Intramedullary refers to being inside the bone.
MRI: MRI refers to Magnetic Resonance Imaging, which is a medical technique to visualize
structures inside the body.
Osteopenia: Osteopenia is a condition where the density of your bone is lower than normal.
Pacemaker: An artificial device for stimulating the heart muscle and regulating its contractions.
Precice Device: The Precice device is the adjustable implant that is implanted into your leg bone
(tibia or femur). It is lengthened by the ERC from outside your body.
Regenerate: Regenerate refers to new growth. In this manual, it refers to new bone tissue
growth.
Stall: This indicates that the ERC is not lengthening properly.
Troubleshooting: The process of solving problems or why something does not operate correctly.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 9of 45
4) INDICATIONS FOR USE: WHY IS PRECICE USED?
The Nuvasive Specialized Orthopedics, Inc. (NSO) External Remote Controller, model ERC
3P, is a portable hand-held device used to non-invasively extend or retract the Precice Family
Systems.
The Indications for Use of the ERC 3P when used with the Precice System (inclusive of
Precice Unyte, Precice Stryde, and Precice Bone Transport) is indicated for limb-lengthening,
open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions or bone transport
of long bones.
The Indications for Use of the ERC 3P when used with the Precice Plating System is indicated
for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-
unions of long bones in pediatrics and small stature adult patients.
The Indications for Use of the ERC 3P when used with the Precice Ankle Salvage System is
intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle
Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-
unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device
may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been
achieved.
After your doctor implants the Precice device into your leg, you will use the ERC to make the
device longer. The lengthening phase usually starts 5 days after your surgery. You will make
the Precice device a small amount longer each day (usually about 0.75 to 1 millimeter each
day). This phase of your treatment could last up to 80 days. Your doctor will tell you how
much and how often to adjust the Precice device. Usually once a week you will visit your
doctor to check on your progress. Your doctor may x-ray your leg during these visits. Your
doctor will also tell you to use crutches and avoid putting weight on your leg with the Precice
device. A good result requires your active cooperation and dedication to certain tasks. If you
do not follow your doctor’s instructions, you could seriously harm yourself.
After your leg has reached its goal length, you will stop using the ERC. This will let your bone
heal.
During the consolidation phase, the bone heals. Your bone will change, or regenerate, from a
soft material into hard bone over time. This healing process usually takes about 2 months for
every inch that your bone has been lengthened. During this healing phase, it is very important
that you follow all of your doctor’s instructions. You will continue to see your doctor for
visits, usually once a month.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 10 of 45
5) CONTRAINDICATIONS: WHO CANNOT USE THE PRECICE SYSTEM?
Important Safety Information – Read Before Use!
Please read and consider the information in this guide before deciding on
your treatment.
This section describes the Contraindications for the Precice System. Tell your doctor if you
have any of the listed conditions. Your doctor must not recommend the Precice system for
you if you do. It is important your doctor has your full medical history to recommend the best
way to treat your condition. He or she may recommend something that can be very harmful if
they do not know your medical background.
CONTRAINDICATIONS:
Your doctor will check the following to see if you would be a good fit for the Precice System
(inclusive of Precice IMLL, Precice Unyte, Precice Stryde and Precice Bone Transport):
•Patients with an irregular bone diameter that would prevent insertion of the Precice nail.
•Patients in which the Precice nail would cross joint spaces or open epiphyseal growth plates.
•Patients in which there is an obliterated medullary canal or other conditions that tend to
retard healing such as blood supply limitations, peripheral vascular disease or evidence of
inadequate vascularity.
•Patients unwilling or incapable of following postoperative care instructions.
•Infection or Pathologic conditions of bone such as osteopenia which would impair the ability
to securely fix the device.
•Patients with Gustilo open fracture Classification Grade IIIB or IIIC fractures
•Patients with pre-existing nerve palsies
•Metal allergies and sensitivities.
Precice Bone Transport has the following additional contraindications:
•Patients with maximum bone defect of more than 100 mm.
•Patients with excessive skin damage and inadequate soft tissue covering of the fracture sites.
Please refer to the tables below for contraindications with regard to weight and maximum
distance of the treated limb to the surface of the intramedullary canal.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 11 of 45
For Precice & Precice Unyte Nail
Limb
PRECICE
Model
Nail Diameter
Maximum Distance of
Treated Limb to Surface
of IM Canal
Maximum
Patient Weight
8.5 mm, 9.0 mm, 9.5 mm,
10.0 mm, 10.5 mm
13 mm
57 Kg
C
10.7 mm, 11.5 mm, 12.5 mm
16 mm
114 kg
8.5 mm
13 mm
57 Kg
J
10.7 mm, 12.5 mm
16 mm
114 kg
8.5 mm
13 mm
57 Kg
Tibia
Q
10.7 mm
16 mm
57 Kg
8.5 mm, 9.0 mm, 9.5 mm,
10.0 mm, 10.5 mm
45 mm
57 kg
10.7 mm, 11.5 mm
75 mm
114 kg
A-G (except
C), V, X
12.5 mm
90 mm
114 kg
8.5 mm
45 mm
57 kg
10.7 mm
75 mm
114 kg
H, K, U
12.5 mm
90 mm
114 kg
8.5 mm
45 mm
57 kg
Femur
N, M, P
10.7 mm
75 mm
57 kg
165 - 210 mm
pre-distracted
length
25 mm
Non-weight
bearing
Humerus
L, M
8.5mm
225 - 300 mm
pre-distracted length
45 mm
Non-weight
bearing
For Precice Stryde Nail
Limb
PRECICE
STRYDE
Model(s)
Nail
Diameter
Maximum Distance of
Treated Limb Surface to
IM Canal
Maximum
Patient
Weight
10.0
13mm
150 lbs / 69 kg
11.5
16mm
200 lbs / 91 kg
Tibia
C, SJ
13.0
16mm
250 lbs / 114 kg
10.0
70mm
150 lbs / 69 kg
11.5
85mm
200 lbs / 91 kg
Femur
A, B, C,
E, V, X
13.0
100mm
250 lbs / 114 kg
For Precice Bone Transport Nail
Limb
PRECICE
STRYDE™
Model
Nail Diameter
(mm)
Maximum Distance of
Treated Limb Surface
to IM Canal
Max. Patient Weight
Bearing
Use with partially
threaded screws
Max. Patient Weight
Bearing
Use with fully threaded
screws
10.0
19mm
25lbs/11kg
25lbs/11kg
11.5
19mm
190lbs/86kg
125lbs/57kg
Tibia
C, SJ
13.0
19mm
250lbs/114kg
125lbs/57kg
10.0
64mm
25lbs/11kgs
25lbs/11kg
11.5
69mm
190lbs/86kg
125lbs/57kg
Femur
A, B, BT, D, DT,
E, V, X, SE, SB,
SD, SA
13.0
85mm
250lbs/114kg
125lbs/57kg

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Contraindications for the Precice Plating System:
•Infection or pathologic conditions of bone such as osteopenia which would impair the ability
to securely fix the device.
•Patients with Gustilo-Anderson open fracture Classification Grade IIIB or IIIC fractures
•Metal allergies and sensitivities.
•For the femur, patients whose distance from the skin surface to the Precice Plate is greater
than 38mm. For the tibia, patients whose distance from the skin surface to the Precice Plate is
greater than 20mm.
•Patients with an irregular bone shape/size that would prevent placement of the Precice Plate.
•Patients whose condition tend to retard healing such as blood supply limitations, peripheral
vascular disease or evidence of inadequate vascularity.
•Patients unwilling or incapable of following postoperative care instructions.
Contraindications for the Precice Ankle Salvage System:
•Active infection or pathologic conditions of bone such as osteopenia which would impair the
ability to securely fix the device.
•Patients with an insufficient quantity or quality of bone to permit fusion of the joints or
stabilization of the arthrodesis.
•Patients with an insufficient plantar pad.
•Patients having an intact asymptomatic subtalar joint.
•Patients with Gustilo open fracture Classification Grade IIIB or IIIC fractures.
•Metal allergies and sensitivities.
•Patients with an irregular bone diameter that would prevent insertion of the Precice Ankle
Salvage nail.
•Patients in which there is an obliterated medullary canal or other conditions that tend to
retard healing such as blood supply limitations, severe peripheral vascular disease or
evidence of inadequate vascularity.
•Patients with severe longitudinal deformity
•Patients with significant tibial malalignment (>10 degrees in either sagittal or coronal plane)
•Patients unwilling or incapable of following postoperative care instructions.
•Patients whose maximum distance of treated limb surface to IM canal exceeds 25mm.

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6) WARNINGS AND CAUTIONS: WHAT MUST YOU DO TO AVOID SERIOUS HARM?
This section describes the Warnings associated with the ERC 3P. This will help you to avoid
serious harm when using the ERC 3P. Please read all of these warnings before you use ERC
3P.
* WARNING *
Weekly X-ray imaging to assess actual distraction length is recommended for
patients undergoing lengthening.
* WARNING *
During and after compression, X-ray imaging is recommended to assess
compression and bone healing.
* WARNING *
Proper training of the External Remote Controller is required prior to
operating this device. Only use the External Remote Controller in a manner
consistent with this Operator’s Manual. Any alternative use may result in
injury or damage to property.
* WARNING *
This equipment may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as
re-orienting or relocating the External Remote Controller or shielding the
location.
•*WARNING*
This device should not enter a Magnetic Resonance Imaging (MRI) unit or
MRI environment.
Avoid all places labeled as having a strong magnetic field. PRECICE implant is
unsafe in Magnetic Resonance Imaging (MRI) environments.
* WARNING *
Persons with a pacemaker or a similar medical aid should not handle or be
exposed to the External Remote Controller. The strong magnetic fields may
affect the operation of such devices.

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Model: ERC 3P
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* CAUTION *
The Rare-Earth Magnetics Association is not aware of any positive or negative
health effects from handling rare-earth magnets. However, it is recommended
that pregnant women not handle very strong rare-earth magnets (ERC).
* WARNING *
The External Remote Controller uses strong permanent magnets. Misuse of
this system can cause serious personal injury. Always maintain a firm grip on
the External Remote Controller and be aware of other objects in your work
area. The External Remote Controller may be pulled away from your hands,
or items may be pulled toward it if brought too close to other magnetic objects.
Make sure there is at least 2 feet (60 centimeters) around the work area that is
free of metal objects such as instruments and tools before use. This includes
personal items such as jewelry, watches, keys, and cellular phones. Do not use
the ERC with metal/magnetic objects within the designated vicinity.
* WARNING *
If this equipment is damaged, beware that magnet shards from broken
magnets are very sharp. Always handle broken magnets with thick protective
gloves. Contact Nuvasive Specialized Orthopedics if the ERC is damaged.
* WARNING *
Never place the External Remote Controller near electronic media or
appliances. The strong magnetic field may damage magnetic media such as
floppy disks, credit cards, magnetic I.D. cards, cassette tapes, video tapes or
other such devices. It can also damage televisions, VCRs, computer monitors
and other CRT displays.
* WARNING*
Never operate in ERC in an oxygen enriched or flammable environment.
* WARNING *
There are no user serviceable components inside this device. Do not open the
unit. Severe personal injury or damage to the equipment may result. Service
should only be performed by qualified personnel.

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* WARNING *
Only use the supplied power cord for the ERC or an equivalent hospital grade
cord rated for 10 Amps minimum. Contact Nuvasive Specialized Orthopedics
for a replacement power cord.
* WARNING *
Do NOT use this equipment in the presents of flammable anesthetics.
* WARNING *
The ERC should only be placed immediately over the area of the patient’s
body at the magnetic portion of the implant. Do not place the ERC near any
other parts of the body, for example, portions of the body which may contain
ferromagnetic material containing implants. When the ERC is not being
actively used on the patient, it should always be kept within its protective case.
*WARNING*
If, during implant adjustment, the ERC magnets fail to stop rotating, move the
ERC at least 12 inches (30 centimeters) from the skin. This will undo the
magnetic coupling between the ERC and the implant and will stop the
adjustment. Place the ERC in its protective case and power off the unit.
Unplug the device from the charging cord if the ERC is plugged in.
*WARNING*
If the ERC loses power during implant adjustment, contact Nuvasive
Specialized Orthopedics before continuing the implant adjustment.
*WARNING*
Do not leave the ERC unattended around children. The ERC is not intended
to be used by anyone under the age of 18. Use of this device by anyone under
the age of 18 may result in improper use which may result in the need for
another surgery.
* WARNING*
Do not operate the ERC if it is dropped from a height of 3 feet or greater. If
there is physical damage to the unit (e.g. unexpected noise, cracks) do not
operate. If this does occur, please call the manufacturer NuVasive Specialized
Orthopedics, Inc. and a replacement unit will be provided.
*WARNING*
Do not lift the ERC unit using the adapter cord. Please return with ERC.

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*WARNING*
Always follow the prescription and instructions from your doctor when using
the ERC. If you do not follow your prescription, your bone could heal
improperly or not at all.
If you use the ERC less often than your doctor prescribes, your bone might
harden too early. It will also stop getting longer before it has reached its target
length. If this happens, you may need another surgery to make your bone the
right length.
If you use the ERC more than your doctor prescribes, you could lengthen the
bone too quickly. This causes your bone to heal improperly or not at all. If this
happens, you may need another surgery to treat the bone that will not heal.
*WARNING*
Always put the ERC on the skin directly over the implant and in the correct
direction. Placing the ERC in the wrong location on your limb could result in
the bone not lengthening correctly. Your bone could harden too early if it is not
lengthening or shortened correctly. You may need another surgery to make your
bone the right length.
*WARNING*
Align the ERC toward the patient’s feet as in the picture below. The Display
screen should be facing you so it can be read. If the ERC is pointing in the wrong
direction, the Precice implant will not lengthen or shorten properly and may
result in the need for another surgery. This figure shows the correct direction to
point the ERC.
*WARNING*
To avoid infection, do not place the ERC on any open sore on your skin. You
may need medical intervention or surgery to treat an infection. An open sore is
any cut on your skin.

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*WARNING*
Always discuss any pain or discomfort you are having with your doctor. This
treatment may cause some pain and discomfort. This could be a normal part of
your treatment or a symptom of other issues. Your doctor may want to adjust
your prescription during your treatment if you are experiencing pain or
discomfort.
*WARNING*
Before you use the ERC, make sure you receive training from your doctor or
nurse. Improper use of the ERC could cause your bone to harden too soon or
not at all. This could result in the need for another surgery.
*WARNING*
Follow the instructions your doctor gives to you about how much weight to put
on your leg during your treatment. If you put more weight on your leg than
your doctor recommends, the device could be damaged or break. This could
result in the need for another surgery.
*WARNING*
Do not put the ERC near any areas that may have extreme temperatures.
Some areas may include a heater or fireplace. Extreme temperatures would be
anything above 140ºF/60ºC or below 14ºF/-10ºC. The ERC has not been tested
in those temperatures. Refer to the Troubleshooting section if you have any
problems with the ERC.
*WARNING*
Act on all error messages. Refer to the Troubleshooting section to learn how to
respond to an error message. Failure to take action after an error message
could result in the ERC not working properly.

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7) RISKS: WHAT ARE THE RISKS OF THIS PROCEDURE?
There are risks of the surgery to implant the Precice implant into your limb. The anesthesia
and surgical risks are the same as for any patient who undergoes a surgical procedure. The
risks listed could result in the need for additional medical or surgical procedures to correct.
The risks associated with anesthesia and surgery include:
•You could have a reaction to the medicines given to you during the surgery.
•You could get an infection during or after the surgery.
•You could have an embolism during or after the surgery.
•You could experience some stiffness or soreness from the surgery.
•You could experience some pain from the surgery.
•You could experience some bleeding from the surgery.
•You could have an allergic reaction to the medicines.
•You could have an allergic reaction to the devices used to treat you during the surgery.
•You could have a stroke from the surgery.
•You could have a heart attack (Myocardial infarction) from the surgery.
•You could get pneumonia from the surgery.
•You could die from the surgery.
The additional potential risks of the limb lengthening procedure include:
•You may feel pain from lengthening your bone.
•There may be a delayed union or non-union of the bone (the bone does not heal).
•The screws may pull out or break.
•There may be an infection.
•The implant may malfunction or break.
•The bone can consolidate (harden) before the lengthening is complete.
•You may have stiffness of the soft tissue in your leg that may cause pain.
•You may experience muscle weakness from not using the implanted limb.
•You may experience nerve injury.
The additional risks associated with the use of the ERC include:
•Misalignment or improper location of the ERC can result in the implant not lengthening
which could result in premature bone consolidation.
•Placing the ERC in the wrong direction can result in shortening of the implant rather
than lengthening. Note that the implant cannot be shortened less than its initial
programmed length.
•Over distraction could occur due to improper programming of the ERC by the
physician. This could result in non-union of your bone.

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8) PRODUCT DESCRIPTION: ABOUT YOUR PRECICE IMPLANT AND ERC
What is PRECICE? The PRECICE System includes:
•An adjustable implant device that goes into your leg or arm bone and is capable of adjusting
in length
oThe actuator is the part of the device that can change in length when activated
•Screws that attach the device to your bone
•An External Remote Controller (ERC)
The adjustable implant device has a part called an “actuator” that can change length. The
actuator has a small magnet that allows the device to get longer when the magnet is turned by
the ERC. The ERC is a hand held device with two large magnets. The magnet in the actuator
turns when the ERC is placed on your leg and turned on. When the device gets longer, your
leg bone will also get longer.
Figure 1: Precice device implanted in the Femur

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 20 of 45
What happens during and after the treatment?
There are 4 phases to your treatment.
1) Implantation: This phase is when you have your surgery. Your doctor implants the
Precice device in your leg.
2) Lengthening: You will make your leg longer each day in this phase. About 5 days after
your surgery, you will visit your doctor to have your first lengthening. Your doctor will
watch you while you use the ERC to make your leg longer and answer any questions
you might have. When you are at home, you will use the ERC to make your leg a little
longer each day (usually about 1 mm per day). Make sure you follow your doctor’s
instructions. You will visit your doctor about once a week to check on your progress.
Your doctor may x-ray your leg when you visit.
3) Consolidation: After your leg is the right length, you will stop lengthening your leg
each day. Now you will let your leg bone heal and get stronger. This is the consolidation
phase. Your doctor will see you about once a month during this phase to check on your
progress. Your doctor will tell you how much weight you can put on your leg. It is
important to follow all of your doctor’s instructions.
Figure 2: Precice Device Implanted in the Tibia
4) Removal: The Precice device will need to be removed from your leg within a year of
your surgery. Your doctor will schedule another surgery to remove the Precice device.
You will then stay in the hospital after the surgery until you heal enough to go home.
Your doctor will tell you when you can continue your usual lifestyle after you have
fully healed from your surgery.