MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	LP4.5-PRF4B
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be provided.
Event or Problem Description
Information was received that during a routine follow up appointment radiography showed a slight varus bend developing in the plate.The patient completed lengthening, however, they developed varus deformity of the right femur bone.At the time of removal, the deformity was acutely corrected.During the removal procedure a small amount of corrosion was seen at the implant's male/female junction.
Additional Manufacturer Narrative
Device evaluation: upon return, visual inspection of the plate revealed the distraction rod of the plate had incurred discoloration.The reported failure of discoloration has therefore been confirmed.Additionally, the inspection revealed the distraction rod of the plate had a slight bend which has been confirmed in the reported description.At the time of removal, the surgical team suspects the plate bending could be related to abnormally tight hip abductor muscles.It was also noted by the surgery team that the bending was not severe enough to require intervention.Per reported failure functional testing was not applicable and the device met the lengthening goal.Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.
Event or Problem Description
No additional information was received.

• Brand Name: PRECICE PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 12233285
• Report Number: 3006179046-2021-00418
• Device Sequence Number: 19834137
• Product Code: KTT
• UDI-Device Identifier: 00887517021366
• UDI-Public: 887517021366
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LP4.5-PRF4B
• Device Lot Number: 0070201AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR