ENDOSKELETON® TCS 5302-3516Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191375011521), received between Sep 25, 2017 and Feb 27, 2020 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K151596); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A SPINAL DEVICE BEING USED FOR AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (C3-5) CASE. IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE LOCKING SCREW; THE LITTLE COLLAR ON THE LOCKING SCREW CAME OFF WHILE THE SCREW WAS BEING INSERTED. AFTER THE LOCKING SCREW WAS PLACED IN THE PATIENT, THE PHYSICIAN NOTICED THAT THE LITTLE COLLAR PIECE HAD POPPED OFF THE SCREW. TO RESOLVE THIS ISSUE, THE PHYSICIAN REMOVED THE COLLAR PIECE AND THE SCREW, AND ANOTHER SCREW WAS USED IN ITS PLACE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT, AND NONE ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9765123 ↗
• MalfunctionSep 25, 2017Detachment Of Device Component; Component Falling

  DELIVERED ORDER FORM WAS RECEIVED FROM (B)(6) MEDICAL CENTER THAT INDICATED A LOCKING COLLAR FELL OFF ONE OF THE 5302-316 LOCKING BONE SCREWS. FOLLOW UP ON THE DO FORM WAS COMPLETED AND THE FOLLOWING INFORMATION WAS RECEIVED IN REGARDS TO LOCKING COLLAR FALLING OFF OF THE BONE SCREW. THE TCS BONE SCREW WAS BEING ADVANCED INTO THE BONE THROUGH THE IMPLANT WHEN THE LOCKING COLLAR FELL OFF. A TCS U-JOINT DRIVER (P/N 5210-1024) WAS BEING USED TO INSERTER THE BONE SCREW. THE TCS CURVED AWL (P/N 5210-1063) WAS USED TO CREATE THE PILOT HOLE FOR THE BONE SCREW. HOWEVER, NO FLUOROSCOPY WAS USED TO CONFIRM THE TRAJECTORY OF THE PILOT HOLE. IN ADDITION, NO TCS AWL GUIDE WAS USED DUE TO THE SEVERE ANGLE. THE COLLAR WAS REMOVED FROM THE OPERATIVE SITE AND THE SCREW WAS LEFT IN WITHOUT THE COLLAR. AN ACDF PROCEDURE WAS BEING PERFORMED AND SUCCESSFULLY COMPLETED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE LOCKING COLLAR FALLING OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6891593 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151596. One submission often covers many models, so check the product and lot details in each record.

• Z-0086-2022 · Sep 2, 2021 · Terminated
  Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm