Endoskeleton TCS 5302-3516Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M682530235160), received between Feb 27, 2017 and Feb 27, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2017Break; Use of Device Problem; Use of Device Problem

  2 SCREWS WERE USED AND 1 SCREW BROKE. ANOTHER SCREW WENT IN AND OUT AND THE SURGEON DID NOT WANT TO RE-USE IT AFTER UNLOCKING IT FOR FEAR IT WOULD BREAK AGAIN. THE SURGEON USED THE DRILL GUIDE AND THE SCREW BROKE AS HE WAS LOCKING IT IN PLACE. BOTH PIECES WERE REMOVED FROM THE PATIENT AND THE CASE WENT ON. FLUOROSCOPY DID NOT CONFIRM THE DRILL TRAJECTORY BEFORE THE SCREW WAS INSERTED. HAND HELD POLY AXIL DRILL FROM THE SET WAS USED. THE STRAIGHT DRIVER (P/N: 5210-1004) WAS BEING USE AT THE TIME. THE SCREW WAS INSERTED NEARLY ALL THE WAY WHEN IT BROKE OFF. THE SCREW BROKE BEFORE WE GOT TO THE POINT OF USING FLUOROSCOPY AGAIN TO CHECK ITS TRAJECTORY.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 6362786 ↗