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

Model Number PS11.5-80B335

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information has been provided, a supplemental report will be submitted.

Event Description

It was reported that when the nail was removed there was visible oxidization on the nail.In addition x-rays revealed that there was mild hypertrophic bone around the nail junction.

Event Description

Additional information was received.

Manufacturer Narrative

Additional data.

• 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: 11930287
• MDR Text Key: 258956726
• Report Number: 3006179046-2021-00290
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517950864
• UDI-Public: 887517950864
• Combination Product (y/n): N
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS11.5-80B335
• Device Lot Number: 0010303AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR