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

Model Number PS11.5-80SJ280

Device Problem Material Discolored (1170)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

The device has been returned and is pending evaluation.A supplemental report will be submitted with device evaluation findings.

Event Description

Information was received that a nail was explanted due to osteolysis.It was reported the nail had reached its intended length but upon explant, the nail was found to be discolored.The patient received bone grafting and plating.No additional information is available.

Manufacturer Narrative

Evaluation summary: review of the device history record found no discrepancies related to the reported event and the lot met all release criteria.A visual inspection of the returned nail revealed that the distraction rod of the nail had discoloration.The root cause is unable to be determined at this time.

Event Description

No new information provided.

• 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: 11631387
• MDR Text Key: 244379093
• Report Number: 3006179046-2021-00225
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951687
• UDI-Public: 887517951687
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS11.5-80SJ280
• Device Lot Number: 9040906AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention