ACCULIF 800804Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327105940), received between Feb 11, 2016 and Aug 17, 2017 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionAug 17, 2017Mechanical Problem; Difficult To Position; Mechanical Problem; Difficult To Position; Failure to Align

  PER REPORTED EVENT; THE INSERTER FAILED TO LOCK. THIS PROVIDED AN UNSAFE IMPACTION ENVIRONMENT. WE HAD OPENED THE IMPLANT AND TUBING, LOADED THE IMPLANT AND UPON LOADING DISCOVERED THAT THE INSERTER DIDN'T LOCK IN PLACE. WE ENDED UP USING PEEK INSTEAD. PER ADDITIONAL COMMUNICATION, PROCESS TO COMPLETE THE SURGERY DID NOT REQUIRE A LARGER/ADDITIONAL INCISION ON THE PATIENT AND/OR ANY OTHER MEDICAL INTERVENTION THAT WOULD BE DIFFERENT HAD THE CAGE BEEN USED AS PLANNED. FURTHER COMMUNICATION WITH SALES REP ON (B)(6) 2017 INDICATED; THE "UNSAFE IMPACTION ENVIRONMENT" IS REFERRING TO SURGEON INDICATING THAT THE IMPLANT MAY DAMAGE THE DURRA DURING INSERTION. SINCE IMPLANT WAS NOT ABLE TO LOCK, THE IMPLANT WOULD GO BACK AND FORTH DURING INSERTION. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6802327 ↗
• MalfunctionJun 20, 2017Mechanical Problem; Difficult To Position; Break; Mechanical Problem; Difficult To Position; Positioning Problem

  IT WAS REPORTED THAT; ALLEGEDLY THE INSERTER FOR A LUMBAR FUSION SURGERY WOULD NOT POSITION PROPERLY AND SURGEON WAS UNABLE TO IMPLANT SUCCESSFULLY. BACK UP IMPLANT WAS AVAILABLE. ADDITIONAL INFORMATION NOTED THE FOLLOWING; THE CAGE COULDN¿T GET TO POSITION PROPERLY BECAUSE THE LOCKING MECHANISM ON INSERTER BROKE AND IT WAS LEFT IN UNLOCK CAUSING SURGEON TO NOT BE ABLE TO GET FORCE FOR CAGE TO CROSS MIDLINE. THUS, WE HAD TO REMOVE IMPLANT AND USE PEEK CAGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6655691 ↗
• MalfunctionMay 24, 2016Break; Detachment Of Device Component

  IT WAS REPORTED THAT WHILE INSERTING THE CAGE, INSERTER WAS PRESSED AGAINST SCREW POST OF THE RETRACTOR AND AS A RESULT THE CASING OF THE INSERTER WHERE THE TUBING ENGAGES WITH THE HANDLE BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5676088 ↗
• MalfunctionMay 19, 2016Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 5666171 ↗
• MalfunctionMar 29, 2016Entrapment of Device; Leak/Splash; Device Operates Differently Than Expected; Torn Material

  IT WAS REPORTED THAT THE INSERTER WAS DAMAGED DURING THE SURGERY. THE CAGE WOULD NOT EXPAND AND THE INSERTER WAS LEAKING IN THE DISC SPACE. THE CAGE WAS REMOVED AND PEEK SPACER WAS USED. UPON INSPECTION, IT WAS APPARENT THAT THE TUBING HAD GOTTEN CAUGHT IN THE ARTICULATING JOINT OF THE INSERTER AND SUBSEQUENTLY TORN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5531899 ↗
• MalfunctionMar 21, 2016Adverse Event Without Identified Device or Use Problem; Cut In Material; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON TRYING TO INSERT THE CAGE, (AFTER ROTATION OF IMPLANT) THE SURGEON TRIED TO EXPAND THE IMPLANT. SHE FILL THE SYRINGE TWICE. THERE WAS NO EXPANSION. SHE THEN REMOVED THE IMPLANT AND SAW THAT THE INSERTER HAD CUT THE TUBING; REPLACED THE TUBING AND RE-INSERTED THE IMPLANT, SHE THEN TRIED TO EXPAND THE IMPLANT FOR THE SECOND TIME. SALINE IN THE DISC SPACE WAS NOTICED. SO SHE REMOVED THE IMPLANT AGAIN, AND THE INSERTER HAD CUT THE TUBING AGAIN. AT THAT TIME SHE MADE THE DECISION TO SWITCH TO ANTHER TYPE OF INTERBODY DEVICE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5514508 ↗
• MalfunctionFeb 11, 2016Mechanical Problem; Mechanical Problem; Cut In Material; No Pressure; Activation Failure

  IT WAS REPORTED THAT THE INSERTER SLICED THE TUBING AND DID NOT CREATE PRESSURE TO EXPAND. IMPLANT DID NOT EXPAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5432171 ↗
• MalfunctionFeb 11, 2016No Pressure

  IT WAS REPORTED THAT THE INSERTER SLICED TUBING AND LOST PRESSURE. THEREFORE, THE IMPLANT DID NOT EXPAND. SLICING HAPPENED WHEN IMPLANT WAS ROTATED OUTSIDE THE PATIENT BODY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5432169 ↗