Endoskeleton TCS 5302-3814Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M682530238140), received between Jun 10, 2016 and Jun 10, 2016.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 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.

• Jun 10, 2016Device Operates Differently Than Expected

  DURING A MULTI-LEVEL CASE, THE SURGEON USED A CURVED FIXED AWL WITHOUT THE AWL GUIDE TO DRILL THE PILOT HOLES. THE SUPERIOR LEVEL SCREWS GAVE THE SURGEON DIFFICULTY INSTALLING. WHEN THE TCS LOCKING BONE SCREWS REACHED APPROXIMATELY HALF WAY IN, THE SCREWS BEGAN TO PRESS AGAINST THE TCS IMPLANT CAGE AS THE PILOT HOLE ANGLE WAS DEEP. THIS CAUSED THE LOCKING COLLARS OF THE BONE SCREWS TO FALL OFF. THE SURGEON RECOVERED THE LOCKING COLLARS WITH A BAYONET FORCEPS. THE RESCUE SCREW EXTRACTOR WAS USED TO REMOVE THE SCREWS. THE PROCEDURE WAS FINISHED USING ADDITIONAL BONE SCREWS WITH NO FURTHER COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE LOCKING COLLARS FALLING OFF OF THE BONE SCREWS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5718293 ↗