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

Model Number PS10.0-80SJ265

Device Problem Material Discolored (1170)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

The device has been returned and is pending device evaluation.Root cause cannot be confirmed at this time.

Event 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 Description

No additional information was made available.

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
• Type of Device: 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
• MDR Text Key: 232158279
• Report Number: 3006179046-2021-00123
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951601
• UDI-Public: 887517951601
• Combination Product (y/n): N
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization