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

Model Number	PS10.0-80SJ265
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and is pending device evaluation.Root cause cannot be confirmed at this time.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2021.As per the reporter, the patient developed pain at the treated limb and has indications of a periostitis and increased c-reactive protein (crp).Additionally, it was reported that the nail had bony changes.
Event or Problem Description
No additional information was made available.
Additional Manufacturer Narrative
Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections and release criteria prior to release.Device evaluation: visual inspection of the returned nail revealed that the distraction rod of the nail had discoloration.This issue is being investigated through the capa process.

• 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: 11336188
• Report Number: 3006179046-2021-00123
• Device Sequence Number: 14578554
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 8101163AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/14/2021
• 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