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

Model Number	PS10.0-80SJ265
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause cannot be determined at this time.The reported event has been addressed in the device labeling.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the nail was not lengthening and had to be exchanged.No patient injury was reported.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
Device records review: a review of dhr for the returned unit confirmed that it met all the required quality inspection criteria prior to release.Device evaluation: the returned nail was observed and no damage was found.X-ray images of the internal components showed no damage and revealed the nail was partially distracted.The nail was functionally tested and was able to distract and retract with the erc and high-speed magnet.The maximum and minimum lengths were measured and found to meet specification.Distraction force testing was measured and found to meet specification.Thus, based on this investigation, the failure mode could not be confirmed.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11156990
• Report Number: 3006179046-2021-00107
• Device Sequence Number: 14328129
• Product Code: HSB
• UDI-Device Identifier: 00887517951601
• UDI-Public: 887517951601
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: PS10.0-80SJ265
• Device Lot Number: 9100406AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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: Hospitalization