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

Model Number	PS10.0-50D235
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation nor were radiographs or images provided to confirm the alleged event.Even though root cause cannot be confirmed based on reported information premature consolidation of patient's bone may have contributed to the alleged event.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the nail failed to lengthen.
Additional Manufacturer Narrative
The customer¿s report that the nail failed to lengthen was not confirmed; the returned precice stryde was observed and no damage was found.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 erc and high speed magnet.The root cause for the customer¿s report was not determined.Review of the device history record for the nail confirmed that it met all the required quality inspections.Complaint records show similar failures reported in the past.
Event or Problem Description
Correction: d.4 (lot number).

• Brand Name: PRECICE STRYDE 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: 9751914
• Report Number: 3006179046-2020-00115
• Device Sequence Number: 2412047
• Product Code: HSB
• UDI-Device Identifier: 00887517951168
• UDI-Public: 887517951168
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS10.0-50D235
• Device Lot Number: 9102801AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERC 2
• Patient Age: 13 YR