ACCULIF 800044Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327105926), received between Mar 8, 2016 and Jul 11, 2016 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2016Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INSERTER TIP WAS DAMAGED AND WOULDN'T ALLOW THE IMPLANT TO FULLY SEAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5784156 ↗
• MalfunctionMay 19, 2016Break

  IT WAS REPORTED THAT THE AREA WHERE TUBING CLICKS INTO INSERTER HANDLE IS STRIPPED. TUBING DOES NOT CLICK IN AND THUS UNABLE TO EXPAND THE CAGE. BOTH TL AND PL SETS WERE USED AND BOTH FAILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5666170 ↗
• MalfunctionMay 13, 2016Break; Fracture; Device Dislodged or Dislocated; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; WHILE IMPACTING THE INSERTER, THE METAL CAP THAT IS WELDED TO THE DISTAL TIP BECAME DISLODGED DURING INSERTION INTO THE DISC SPACE. IT SUBSEQUENTLY TURNED THE CAGE 90 DEGREES ON THE DISTAL TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5654791 ↗
• MalfunctionApr 11, 2016Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT A DISTAL END OF THE INSERTER BROKE OFF. THE SURGEON HAD INSERTED A CAGE SUCCESSFULLY ON THE PATIENT'S RIGHT SIDE. HE WAS THEN INSERTING A SECOND CAGE ON THE PATIENT'S LEFT SIDE AND OBSERVED UNDER FLOURO THAT THE IMPLANT WAS TO ANTERIOR. SO HE REQUESTED A SLAP HAMMER. UPON USING THE SLAP HAMMER A COUPLE OF STRIKES, THE INSERTER HAD A LOT OF SLACK AND IT WAS CONCERNED THE IMPLANT HAD COME LOOSE. UPON FLOURO OBSERVATION, THE IMPLANT WAS STILL ATTACHED AND THE SURGEON WAS ABLE TO GET THE IMPLANT MOVED TO THE IDEAL LOCATION. THE IMPLANT WAS THAN EXPANDED SUCCESSFULLY TO THE IDEAL HEIGHT. UPON REMOVAL OF THE INSERTER IT WAS OBSERVED THAT THE DISTAL END OF THE INSERTER HAD BROKEN OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5567922 ↗
• MalfunctionMar 8, 2016Fracture; Fracture; Material Separation

  IT WAS REPORTED THAT THE TIP OF AN INSERTER SEPARATED FROM THE INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5485512 ↗