ENDOSKELETON® TCS 5302-3514Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00191375011507), received between Mar 23, 2018 and Jun 9, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A ACDF PROCEDURE IN A PATIENT DIAGNOSED WITH CERVICAL SPONDYLOSIS. IT WAS REPORTED THAT THE STAPLE HEAD LOCKING RING WAS BROKEN AND LOCKING FAILED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATE RECEIVED ON 22 JUL 2025: EVENT DID NOT OCCUR DUE TO USER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443026 ↗
• MalfunctionOct 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A ACDF PROCEDURE IN A PATIENT DIAGNOSED WITH CERVICAL SPONDYLOSIS. IT WAS REPORTED THAT THE STAPLE HEAD LOCKING RING WAS BROKEN AND LOCKING FAILED. EVENT DID NOT OCCUR DUE TO USER ISSUE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23274314 ↗
• MalfunctionMay 13, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A SPINAL DEVICE BEING USED FOR AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) CASE. THE PRE-OPERATIVE DIAGNOSIS FOR THE ACDF PROCEDURE WAS STENOSIS, AND THE LEVELS IMPLANTED WERE C3-4. IT WAS REPORTED THAT, INTRA-OPERATIVELY, THE LOCKING MECHANISM ON THE SCREW CAME OFF WHILE SCREWING INTO THE STANDALONE CAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT, AND THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10050210 ↗
• MalfunctionMar 10, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A SPINAL DEVICE BEING USED FOR A 3 LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) CASE. THE ACDF PROCEDURE WAS BEING PERFORMED TO TREAT SPINAL STENOSIS, AND THE LEVELS IMPLANTED WERE C4/5, C5/6, AND C6/7. IT WAS REPORTED THAT DURING THE PROCEDURE THE LOCKING SCREW'S LOCKING CAP SHEARED OFF THE SCREW. THE SURGEON TRIED INSERTING THE LOCKING SCREW INTO THE C4/5 BODY. AFTER USING A CURVED FREE HAND AWL INTO THE DEVICE, THE SURGEON DROVE THE LOCKING SCREW THROUGH THE SPACER INTO THE BONE. UPON REACHING THE LIP OF THE SPACER, THE LOCKING CAP SHEARED OFF THE SCREW AND INTO THE INCISION SITE. EVERYTHING WAS RECOVERED, AND THE CAP AND SCREW SHAFT WERE REMOVED FROM THE PATIENT, CONFIRMED BY FLUOROSCOPIC IMAGING. NO FURTHER PROBLEMS AROSE THEREAFTER. THE CURVED VARIABLE AWL WAS USED TO MAKE A NEW TRAJECTORY, AND A NEW SCREW WAS INSERTED INTO THE NEW TRAJECTORY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS, AND THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9811617 ↗
• MalfunctionMar 23, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE LOCKING COLLAR DISASSOCIATED FROM THE SCREW WITHOUT BEING USED IN THE SUBJECT SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 7366845 ↗

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