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

Model Number	PS11.5-80SJ280
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.A supplemental report will be submitted with device evaluation findings.
Event or Problem 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.
Additional 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 or Problem Description
No new information provided.

• 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: 11631387
• Report Number: 3006179046-2021-00225
• Device Sequence Number: 3658108
• Product Code: HSB
• UDI-Device Identifier: 00887517951687
• UDI-Public: 887517951687
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 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
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/07/2021
• 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: Required Intervention