ENDOSKELETON® TA 2106-1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375000426), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionFeb 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE THREADED TIP OF THE SLAP HAMMER BROKE OFF INTO THE HANDLE OF THE THREADED INSERTER. THE INCIDENT OCCURRED DURING AN ALIF L3-S1 PROCEDURE WHILE REMOVING THE RASP FROM L4-5. THE SURGEON DID NOT USE THE RASPS ANY FURTHER. AS AN ALTERNATIVE, THE PHYSICIAN USED SMOOTH DILATORS. THERE WERE NO REPORTED ADVERSE EFFECTS OR INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287589 ↗