IdentiTi 232-10-85-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00190376369990), received between Apr 7, 2022 and Jul 24, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 26, 2024Class IIOpen, Classified

   Due to reports of intraoperative graft bolt implantation breakages.

   Z-1182-2024 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionJul 24, 2025Break; Break

  A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) ON (B)(6) 2025. THE GRAFT BOLT BROKE UPON INSERTION INTO THE STANDALONE CAGE. HALF OF THE BOLT REMAINS STUCK IN THE THREADS OF THE ALIF CAGE AND ENDPLATE OF THE VERTEBRAL BODY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587193 ↗
• MalfunctionJul 1, 2025Break; Break

  A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT THE L4-L5 LEVEL. DURING THE PROCEDURE, NO HOLE PREPARATION WAS PERFORMED PRIOR TO SCREW INSERTION. WHILE INSERTING THE FIRST GRAFT BOLT INTO THE INTERBODY SPACER, THE INSERTION ANGLE WAS TOO SHALLOW, RESULTING IN BOLT BREAKAGE. THE BROKEN BOLT WAS REMOVED, AND THE SPACER WAS REPOSITIONED. A SECOND ATTEMPT TO PLACE A GRAFT BOLT ALSO RESULTED IN BREAKAGE; HOWEVER, THE FRACTURED BOLT MAINTAINED ADEQUATE BONY PURCHASE AND WAS LEFT IN PLACE, ALONG WITH THE LATERAL SCREWS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS, AND THE PATIENT IS CURRENTLY DOING WELL POSTOPERATIVELY. THIS IS REPORT 2 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 22377671 ↗
• MalfunctionJul 1, 2025Break; Break

  A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT THE L4-L5 LEVEL. DURING THE PROCEDURE, NO HOLE PREPARATION WAS PERFORMED PRIOR TO SCREW INSERTION. WHILE INSERTING THE FIRST GRAFT BOLT INTO THE INTERBODY SPACER, THE INSERTION ANGLE WAS TOO SHALLOW, RESULTING IN BOLT BREAKAGE. THE BROKEN BOLT WAS REMOVED, AND THE SPACER WAS REPOSITIONED. A SECOND ATTEMPT TO PLACE A GRAFT BOLT ALSO RESULTED IN BREAKAGE; HOWEVER, THE FRACTURED BOLT MAINTAINED ADEQUATE BONY PURCHASE AND WAS LEFT IN PLACE, ALONG WITH THE LATERAL SCREWS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS, AND THE PATIENT IS CURRENTLY DOING WELL POSTOPERATIVELY. THIS IS REPORT 1 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 22377436 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE, THE GRAFT BOLT SNAPPED IN HALF DURING INSERTION.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721471 ↗
• InjuryMar 21, 2025Device Damaged by Another Device; Damaged Thread; Device Damaged by Another Device; Damaged Thread

  DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE, A GRAFT BOLT WAS BEING INSERTED INTO THE SPACER, AND MINIMAL RESISTANCE WAS EXPECTED AS THE BOLT HEAD THREADS ENGAGED. HOWEVER, THE BOLT APPEARED TO PASS THROUGH THE CAGE WITHOUT PROPERLY LOCKING. RADIOGRAPHIC IMAGING SHOWED THAT THE DISTAL THREADED PORTION OF THE BOLT HAD GONE THROUGH THE CAGE, POTENTIALLY BREACHING THE SPINAL CANAL. THE BOLT AND SPACER WERE SUBSEQUENTLY REMOVED AND REPLACED WITH NEW HARDWARE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668204 ↗
• MalfunctionSep 14, 2023Break; Break

  ON (B)(6) 2023, A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE. AFTER INSERTING THE SPACER, PILOT HOLE PREP WAS PERFORMED FOR THE GRAFT BOLT USING THE TREPHINE PUNCH. THE TREPHINE WAS PROPERLY SEATED IN THE CENTER HOLE AND DEPLOYED. IT WAS REPORTED HALF-WAY DURING INSERTION THE GRAFT BOLT SNAPPED. THE TOP PORTION WAS REMOVED LEAVING THE THREADED END WITHIN IN THE SPACER IMPLANTED IN THE PATIENT. LASTLY, THE SURGEON IMPLANTED POSTERIOR PERCUTANEOUS PEDICLE SCREWS. AT THE END OF THE PROCEDURE, IT WAS REPORTED THE SPACER WAS WELL PLACED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17748399 ↗
• MalfunctionJul 27, 2023Break; Break

  THE THREADS ON THE PROXIMAL END OF THE GRAFT BOLT THAT LATCH INTO THE CAGE REPORTEDLY SHEARED OFF. THE GRAFT BOLT WENT STRAIGHT THROUGH THE CAGE AND WOULDN'T LOCK. THE SURGEON REMOVED THE GRAFT BOLT AND IMPLANTED A SCREW THAT LOCKED INTO THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406780 ↗
• InjuryApr 7, 2022Break; Break

  ON (B)(6) 2022, A GRAFT BOLT FRACTURED INTO THE VERTEBRAL BODY OF A PATIENT. THE DISTAL PORTION OF THE GRAFT BOLT REMAINS IN-SITU AS IT WAS SEVERAL MM INTO THE BONE AND COULD NOT BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044350 ↗