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

Model Number	PS10.0-65SJ250
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographs provided did not confirmed the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that a revision procedure occurred on (b)(6) 2019.As per reporter, the nail was unable to distract.
Additional Manufacturer Narrative
The nail was received for functional and visual testing and the reported event was confirmed.The root cause of the reported event was a result of excessive cyclic loading of the thrust bearing potentially due to patient non-compliance.

• 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: 9498359
• Report Number: 3006179046-2019-00184
• Device Sequence Number: 2967090
• Product Code: HSB
• UDI-Device Identifier: 00887517951588
• UDI-Public: 887517951588
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: PS10.0-65SJ250
• Device Catalogue Number: PS10.0-65SJ250
• Device Lot Number: 8082810
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 09/22/2020
• 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: 17 YR
• Patient Weight: 50