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

Model Number	PS11.5-80A265
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ.X-ray images provided confirm the alleged event.Root cause is unable to be determined at this time.The reported event is addressed in the device labeling.
Event or Problem Description
Information was received that the patient is showing bony changes in the junction of the nail and experiencing pain.There is no planned procedure at this time nor change in treatment plan.No patient injury was reported.

• 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: 11033887
• Report Number: 3006179046-2020-00505
• Device Sequence Number: 13711668
• Product Code: HSB
• UDI-Device Identifier: 00887517950628
• UDI-Public: 887517950628
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: PS11.5-80A265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR