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

Model Number PS10.0-50B235

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 after being explanted, the nail was noted to have corrosion on the proximal portion of the lengthening rod.No patient impact or adverse event was reported.No additional information is available.

Manufacturer Narrative

The returned nail was received for visual and functional testing.Visual inspection of the nail revealed that the distraction rod of the nail had visible evidence of discoloration at the junction.Per reported failure functional testing was not applicable.The root cause of the corrosion identified on the nail is currently being investigated.Review of the device history records indicated the precice-stryde nail was visually inspected, and functionally tested prior to release.

Event Description

No additional information has been provided.

• 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: 12089621
• MDR Text Key: 259629866
• Report Number: 3006179046-2021-00322
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517950741
• UDI-Public: 887517950741
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS10.0-50B235
• Device Lot Number: 9092617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1