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

Model Number PS10.0-80D305

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for investigation.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

Information was received that a nail was found to have corrosion at the distraction rod junction and locking screw holes.The nail was said to be otherwise fully functional.There was no report of patient impact in association with the rod.

Event Description

No additional information was received.

Manufacturer Narrative

Device evaluation: visual inspection of the returned nail revealed that the distraction rod of the nail had discoloration which confirmed the reported failure mode.Per reported failure, functional testing was not applicable.A capa has been initiated to address the reported failure.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.

• 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: 11710194
• MDR Text Key: 247011026
• Report Number: 3006179046-2021-00257
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951205
• UDI-Public: 887517951205
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS10.0-80D305
• Device Lot Number: 0042053AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1