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

Model Number P10.7-80C245

Device Problem Defective Component (2292)

Patient Problem Failure of Implant (1924)

Event Date 11/01/2019

Event Type  malfunction  

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 Description

Information was received that a revision procedure was performed on (b)(6) 2019.As per reporter, the nail failed to lengthen.

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 Description

See updated fields d10, h3, h6, h10.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9838903
• MDR Text Key: 188503690
• Report Number: 3006179046-2020-00158
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258020453
• UDI-Public: 812258020453
• Combination Product (y/n): N
• PMA/PMN Number: K173129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 45