ACCULIF 305010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327068061), received between Apr 6, 2016 and Mar 1, 2017 — classified as 2 injuries, 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2017Mechanical Problem; Device Operates Differently Than Expected; Unintended Movement; Mechanical Problem; Unintended Movement

  IT WAS REPORTED THAT; WE, ALONG WITH THE SURGEON, NOTICED THAT THE IMPLANT HAD TOO MUCH TOGGLE ON THE INSERTER, WHICH WAS LOCKED APPROPRIATELY UPON INSERTION INTO THE DISC SPACE. UPON EXAMINATION WE AGREED, AND DETERMINED THE IMPLANT MIGHT NOT EXPAND IN SITU WITH THE TOGGLE. FOR THE SAFETY OF THE PATIENT AND BEST POSSIBLE OUTCOME, WE DECIDED TO TEST THE INSERTER AND IMPLANT ON THE STERILE FIELD BY EXPANDING THE IMPLANT. IT DID EXPAND, HOWEVER, WE DETERMINED THE INSERTER COMPONENTS MIGHT BE DEFECTIVE DUE TO THE EXCESSIVE TOGGLE OF THE IMPLANT ON THE INSERTER, AS WE HAVE NEVER SEEN THIS HAPPEN BEFORE, AND FILE A PER.

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

  MAUDE report 6370588 ↗
• MalfunctionJan 9, 2017Collapse; Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT; THE IMPLANT COLLAPSED ONCE WE WERE FINAL TIGHTENED. WE HAD AP AND LATERAL FILMS OF THE IMPLANT EXPANDED INTRO OP. WE ALSO HAVE AP AND LATERAL FILMS OF THE IMPLANT COLLAPSE ONCE ALL THE SCREWS WERE ALL FINAL TIGHTENED. WE DID NOT REPLACE THE CAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6234129 ↗
• InjuryNov 7, 2016Mechanical Problem; Collapse; Mechanical Problem

  IT WAS REPORTED THAT; SURGEON NOTIFIED SALES REP THAT THE CAGE HE IMPLANTED ON (B)(6) 2016 HAS COLLAPSED. DETAILS AND X-RAYS ARE IN ATTACHED DOCUMENTS.

  Patient problems: No Information; Pain

  MAUDE report 6084339 ↗
• InjuryOct 10, 2016Mechanical Problem; Collapse; Mechanical Problem

  IT WAS REPORTED THAT; THE CAGE COLLAPSED.

  Patient problems: No Information; Pain

  MAUDE report 6015143 ↗
• MalfunctionOct 3, 2016Mechanical Problem; Mechanical Problem; Migration or Expulsion of Device

  IT WAS REPORTED THAT; THE CAGE LOSS OF HEIGHT.

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

  MAUDE report 5994765 ↗
• MalfunctionApr 6, 2016Mechanical Jam; Device Operates Differently Than Expected; Mechanical Jam

  IT WAS REPORTED THAT THE DOCTOR HAD THE IMPLANT ATTACHED TO THE INSERTER EVERYTHING WAS ATTACHED CORRECTLY; TUBING WAS ON THE IMPLANT, THE IMPLANT WAS TAPPED INTO PLACE, TOOK PICTURES, GOT IMPLANT TO GOOD SPOT, TOOK A/P AND LATER X-RAYS AND CONFIRMED THE POSITION WAS GOOD. WENT TO EXPAND THE CAGE AND TRIED TO APPLY THE HYDRAULIC PRESSURE, THE GAUGE WENT UP TOOK PICTURE, AS THE GAUGE WENT UP THE GAUGE SHOWED 1,00-1200 PSI AND WENT DOWN. NO DECREASE WAS MADE BY THE SURGEON. SO THE SURGEON REFILLED WITH SALINE AND PUT THE INSERTER BACK ON THE IMPLANT AND WAS UNABLE TO APPLY ANY MORE PRESSURE. TOOK A LATER VIEW OF THE IMPLANT AND CONFIRMED IT WAS EXPANDED TO ITS DESIRED HEIGHT. ONCE THE INSERTER AND PBR WAS REMOVED THE SURGEON PROCEEDED WITH REST OF THE CASE. THE SURGEON THEN NOTICED THAT THE CAGE WAS EXPANDED HOWEVER THE HEIGHT OF THE CAGE WAS ASYMMETRICAL. THE CAGE WAS PUT IN FOR 10MM AND THE REAR OF THE CAGE WAS EXPANDED TO A 11/12MM, DISCREPANCY BETWEEN THE NOSE AND THE REAR, DOCTOR DID NOT WANT TO REVISE THIS CAGE AND LEFT IMPLANTED. HE WILL OBSERVE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5552632 ↗