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

Model Number PS11.5-80SJ305

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 evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that an explanted nail was noted to have corrosion.No adverse event was reported.No additional information is available.

Manufacturer Narrative

Device evaluation: visual inspection of the returned nail revealed that the distraction rod of the nail had discoloration, which confirmed discoloration failure mode.Per reported failure functional testing was not applicable.The discoloration failure is a previously known issue and is being investigated under a capa.Device history review: a device history review (dhr) was performed on lot number: 9071106 and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.In addition, the nail listed in this complain was built prior of the capa.

Event Description

No additional information.

• 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: 11838684
• MDR Text Key: 251769624
• Report Number: 3006179046-2021-00275
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951694
• UDI-Public: 887517951694
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS11.5-80SJ305
• Device Lot Number: 9071106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1