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

Model Number	PS13.0-80B280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
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 surgery will be performed on (b)(6) 2020.As per reporter, x-ray images revealed that the nail on the left side was not lengthening.
Additional Manufacturer Narrative
The customer¿s report of the nail was not lengthening was not confirmed; the returned precice stryde was inspected 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 of the required quality inspections.Complaint records show similar failures reported in the past.

• Brand Name: PRECICE STRYDE 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: 9783286
• Report Number: 3006179046-2020-00127
• Device Sequence Number: 19299333
• Product Code: HSB
• UDI-Device Identifier: 00887517950918
• UDI-Public: 887517950918
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS13.0-80B280
• Device Lot Number: 9092614AAA
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 03/03/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR