ENDOSKELETON® TO 3114-2614Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375004769), received between Feb 24, 2017 and Feb 24, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• InjuryFeb 24, 2017Device Dislodged or Dislocated

  AN L4/5 TLIF PROCEDURE OCCURRED ON (B)(6) 2016 IMPLANTING AN ENDOSKELETON® TO 0 DEG LORDOTIC, IMPLANT, 26X14MM, PLIF. APPROXIMATELY TWO WEEK LATER, THE PATIENT DESCRIBES HEARING A "POP" IN HER BACK. PATIENT HAD L5 VERTEBRAL FRACTURE. PATIENT WAS SCHEDULED FOR REVISION SURGERY, CAGE WAS REMOVED, PATIENT WAS RE-INSTRUMENTED WITH PEDICLE SCREWS. THERE WAS NO ADVERSE EFFECTS OR INJURY TO THE PATIENT AS A RESULT. THE EXPLANTED DEVICE WAS KEPT AT (B)(6). PATIENT IS A FEMALE, (B)(6), NON-SMOKER. PATIENT DID NOT FALL. PATIENT DOES NOT HAVE PRIOR FUSIONS AT LEVELS THAT WERE BEING TREATED. PATIENT WAS GIVEN POST-OPERATIVE INSTRUCTIONS.

  Patient problems: No Code Available

  MAUDE report 6358584 ↗