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

Model Number PS10.0-65D250

Device Problem Degraded (1153)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.Root cause is unable to be determined at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2021.As per the reporter, periosteal reaction occurred towards the distal tip and distal screw holes during the lengthening process.Metal on metal wear was evident on the nail.No patient injury was reported.

Event Description

No additional information has been provided.

Manufacturer Narrative

Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.Device evaluation: visual inspection of the returned nail revealed that the distraction rod of the nail had discoloration.This issue is currently 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: 11369910
• MDR Text Key: 233252055
• Report Number: 3006179046-2021-00147
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951175
• UDI-Public: 887517951175
• Combination Product (y/n): N
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS10.0-65D250
• Device Lot Number: 0010941AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization