Endoskeleton TCS 5302-3514Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M682530235140), received between Jan 28, 2016 and Jan 28, 2016 — 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 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.

• MalfunctionJan 28, 2016Break; Detachment Of Device Component

  WHILE PERFORMING AN ACDF C4-C7 PROCEDURE TO IMPLANT A TCS 7MM MEDIUM IMPLANT (P/N 5366-1407 LOT# A141204), THE SURGEON HAD A LOCKING COLLAR COME OFF OF ONE SCREW AND THE SCREW HEAD BREAK OFF ANOTHER SCREW. THE SCREW FAILURES OCCURRED WHEN THE SURGEON WAS ADVANCING THE SCREWS WITH A TCS SWIVEL DRIVER. PRIOR TO SEATING THE SCREWS, A TCS CURVED AWL WAS USED TO CREATE THE PILOT HOLES. THE SURGEON WAS ABLE TO SUCCESSFULLY FINISH THE PROCEDURE AT C6/C7 WITH USING DIFFERENT SCREWS. C6/5 WAS AUTO FUSED AND THE SURGEON CHOSE TO USE A DIFFERENT COMPANY IMPLANT AT C4/5. NO HARM CAME TO THE PATIENT DUE TO THE SCREW FAILURES; HOWEVER, SURGERY WAS DELAYED FOR APPROXIMATELY 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5397018 ↗