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

Model Number	P10.7-80C245
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.It is unknown if patient complied with post-operative physical restrictions.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) 2019.As per reporter, the nail failed to lengthen.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned nail showed score marks present on the outer surface of the nail.X-ray images of the internal components showed no damage and revealed the nail to be partially distracted.The nail was functionally tested and was able to distract and retract with the high speed magnet tool.The device met all specifications and the reported defect was unable to be duplicated or confirmed.
Event or Problem Description
See updated fields d10, h3, h6, h10.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9838903
• Report Number: 3006179046-2020-00158
• Device Sequence Number: 742933
• Product Code: HSB
• UDI-Device Identifier: 00812258020453
• UDI-Public: 812258020453
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: P10.7-80C245
• Device Lot Number: 8051104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: 16 YR
• Patient Weight: 45