ENDOSKELETON® TA 2106-1003Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00191375000433), received between Jun 1, 2021 and May 31, 2025 — classified as 4 malfunctions.

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. How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT PRE-SURGERY, THE TRIAL HANDLE BECAME STUCK TO THE TRIAL AND WAS UNABLE TO DETACH IT, AND ANOTHER SET WAS USED. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCTS WERE ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120453 ↗
• MalfunctionApr 21, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DI AGNOSIS FOR ADULT DEFORMITY. PROCEDURE OR TECHNIQUE USED WAS ANTERIOR/POSTERIOR FUSION. LEVELS IMPLANTED 2. IT WAS REPORTED THAT THE PROBE WAS BENT AT THE DISTAL TIP. SCISSOR JACK ASSEMBLY BROKEN/BENT AT THE DISTAL END (WILL NO LONGER OPEN AND CLOSE). THREADS AT THE DISTAL END OF THE INSTRUMENT ARE STRIPPED. BROACHES/RASPS AND DILATORS WILL NO LONGER THREAD ONTO THE HANDLE. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19150141 ↗
• MalfunctionFeb 23, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PRE-OPERATIVE DIAGNOSIS FOR ALIF 4-5. PROCEDURE OR THERAPY PERFORMED WAS L4-5 ALIF. IT WAS REPORTED THAT THE TOP OF THE THREADED HOLDER BROKE OFF WHEN TRIED TO SLAP HAMMER A RASP OUT. THE INTERNAL MECHANISM STRIPPED ON THE DRIVER WHEN INSERTING A SCREW. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589307 ↗
• MalfunctionJun 1, 2021Material Deformation; Material Deformation

  B5: MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS WILL BE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918107 ↗