ENDOSKELETON® TC 5200-1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00191375003793), received between Nov 28, 2025 and Sep 1, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50537535 ↗
• MalfunctionApr 24, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER SPRING WAS BROKEN AND THE AWL POINT WAS WORN DOWN DUE TO NORMAL USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24976964 ↗
• MalfunctionApr 21, 2026Mechanical Problem; Failure to Align

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION AND DIRECT LATERAL INTERBODY FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE TC INSERTERS, THE INSERTER PLI 10 WAS REPORTED TO BE LOOSE ON THE HANDLE, THE INSTRUMENT PLI 20 COULD NOT BE DISASSEMBLED FOR CLEANING BECAUSE THE THREADS WERE STUCK. FOR THE DLIF INSERTER PLI 30, THE INSERTER THREADS WERE REPORTED TO BE CROSS-THREADED AND STUCK IN THE CANNULA. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSTRUMENTS ARE CROSS THREADED / CAN'T BE TAKEN APART FOR CLEANING NO PIECES BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24935542 ↗
• MalfunctionMar 12, 2026Break; Failure to Align

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER INNER SPRING BROKE OFF DURING CLEANING. FOR THE SECOND INSERTER, THERE WAS INABILITY TO UNTHREAD FOR CLEANING, AND FAILURE TO LATCH ONTO INTERBODY CAGES WHEN ATTEMPTED. THESE ISSUES WERE IDENTIFIED BY THE STERILE PROCESSING DEPARTMENT AT THE HOSPITAL PRIOR TO USE AND NOT DURING A PROCEDURE. NO PATIENT WAS INVOLVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584301 ↗
• MalfunctionMar 11, 2026Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION SPINAL THERAPY AT LEVELS C3-5. IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE SHAFT OF THE INSERTER FAILED. IT IS UNABLE TO ATTACH IMPLANTS IN ITS CURRENT CONDITION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574049 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING POST-OP ANTERIOR CERVICAL DISCECTOMY AND FUSION. IT WAS REPORTED THAT INSERTER BROKE AND SPIRING LOST IN SPD UPON CLEANING THE INSTRUMENT. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567785 ↗
• MalfunctionDec 24, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. PROCEDURE INVOLVED IN THIS EVENT WAS ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION). IT WAS REPORTED THAT THE INSERTER NO LONGER FUNCTIONS CORRECTLY. THE RELEASE MECHANISM WON'T FULLY RELEASE THE IMPLANT. THE SURGICAL TECH NOTICED THIS PRIOR TO USING THE INSTRUMENT. THE INSTRUMENT WAS REMOVED FROM THE FIELD. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886556 ↗
• MalfunctionNov 28, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION SPINAL THERAPY WITH A PRE-OPERATIVE DIAGNOSIS OF C5-C6 HERNIATED NUCLEUS PULPOSUS. IT WAS REPORTED THAT THE IMPLANT DOESN'T RELEASE FROM INSERTER. THERE WERE NO PATIENT SYMPTOMS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSERTER WOULD NOT RELEASE THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669302 ↗