ACCULIF 400008Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327066760), received between Mar 4, 2016 and Feb 26, 2018 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Collapse” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2018Migration or Expulsion of Device; Nonstandard Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY IN (B)(6) 2017 DUE TO A MIGRATED IMPLANT. THE PATIENT IS EXPERIENCING PAIN IN THE ABDOMINAL AREA AND IN LOW BACK.

  Patient problems: Injury; Pain

  MAUDE report 7296375 ↗
• MalfunctionJan 6, 2017Collapse; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED; THAT THE CAGE COLLAPSE.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 6230816 ↗
• MalfunctionDec 27, 2016Mechanical Problem; Collapse; Mechanical Problem

  IT IS REPORTED THAT THE CAGE COLLAPSED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6205992 ↗
• MalfunctionDec 21, 2016Mechanical Problem; Collapse; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON MADE AWARE OF A COLLAPSED PL CAGE. CAGE WAS IMPLANTED ON (B)(6) 2014.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6196360 ↗
• InjuryNov 8, 2016Mechanical Problem; Mechanical Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT; IMPLANT HAS REDUCED IN HEIGHT POST OP.

  Patient problems: No Code Available; Pain

  MAUDE report 6087104 ↗
• InjuryAug 15, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT; PATIENT CAME TO THE SURGEON'S OFFICE WITH A REPORT OF BENDING AND HEARING A POP AND MUSCLE SPASMS (ACCULIF COLLAPSE). AT THIS POINT, NO FURTHER SURGICAL PROCEDURES ARE NOT REQUIRED, BUT PATIENT WILL BE MONITORED.

  Patient problems: Muscle Spasm(s); No Code Available

  MAUDE report 5877161 ↗
• MalfunctionJun 21, 2016Collapse; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT; CAGES COLLAPSED.

  Patient problems: No Known Impact Or Consequence To Patient; Pain

  MAUDE report 5740069 ↗
• MalfunctionJun 21, 2016Collapse; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT; CAGES COLLAPSED.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 5740068 ↗
• InjuryJun 13, 2016Collapse; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED REVSION SURGERY FOR A CAGE COLLAPSE.

  Patient problems: Injury; No Information

  MAUDE report 5721523 ↗
• InjuryJun 13, 2016Collapse

  IT WAS REPORTED THAT A REVISION SURGERY OCCURED FOR CAGE COLLAPSE.

  Patient problems: No Code Available

  MAUDE report 5721469 ↗
• InjuryMay 25, 2016Collapse; Mechanical Problem; Noise, Audible; Mechanical Problem

  IT WAS REPORTED THAT; CAGE COLLAPSE WAS NOTICED WHEN PATIENT CAME IN FOR POST OP VISIT AFTER HEARING A POPPING NOISE WHEN BENDING DOWN.

  Patient problems: No Known Impact Or Consequence To Patient; Pain

  MAUDE report 5680285 ↗
• MalfunctionApr 11, 2016Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE SURGEON WAS PLACING THE CAGE AND UPON PLACEMENT HE WANTED TO ARTICULATE THE ARM AND MAKE ADJUSTMENTS. AS HE STARTED TO EXPAND THE CAGE THE SEAL THAT'S ATTACHED TO THE INSERTER WHERE THE TUBING SET ATTACHES BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5567921 ↗
• MalfunctionMar 8, 2016Mechanical Problem; Collapse; Mechanical Problem

  IT WAS REPORTED THAT UPON REGULAR POST OP VISIT, THE CAGE COLLAPSE WAS NOTICED. THERE ARE NO REVISIONS PLANNED, PATIENT IS BEING MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5486225 ↗
• MalfunctionMar 4, 2016Device Dislodged or Dislocated; Device Operates Differently Than Expected; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON INSERTED CAGE INTO A DISC SPACE, EXPANDED IMPLANT TO 3/4 COMPLETE EXPANSION. HOWEVER, WHEN HE RELEASED THE PRESSURE THE IMPLANT WOULD DROP BACK DOWN TO 8MM, THE STARTING HEIGHT. EXPANDING WAS ATTEMPTED 2 DIFFERENT TIMES AND CHANGED THE O RINGS, IT STILL WOULDN'T HOLD ITS EXPANSION. THUS SITUATION ADDED AN EXTRA 5 MINUTES ONTO THE CASE. ENDED UP OPENING A NEW IMPLANT AND EVERYTHING WORKED OUT GREAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5480313 ↗