MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P8.5-50D215
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received and device evaluation is undergoing, findings are not yet available.No x-rays or ultrasound images provided to confirm the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, the nail was broken.Reportedly, the patient was full weight bearing beyond instructions for use.
Additional Manufacturer Narrative
Visual inspection was performed and it confirmed that the nail was broken at the middle of the housing tube.Functional testing could not be performed due to the condition of the nail.The root cause of the reported issue may have been due to stress generated by weight bearing prior to full bone consolidation.A review of the device history record for the nail confirmed no deviations in the manufacturing process and that the finished product met all the required quality inspections.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9965487
• Report Number: 3006179046-2020-00267
• Device Sequence Number: 11399577
• Product Code: HSB
• UDI-Device Identifier: 00812258020583
• UDI-Public: 812258020583
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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: P8.5-50D215
• Device Lot Number: 9032623AAA
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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: 16 YR
• Patient Weight: 60