ACCULIF 305008Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327068054), received between Mar 9, 2016 and Feb 7, 2019 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Collapse” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2019Collapse; Inadequacy of Device Shape and/or Size; Migration; Collapse; Migration

  THE DEVICE WAS IMPLANTED (B)(6) 2016. IN (B)(6) 2017 THE PATIENT BEGAN TO EXPERIENCE PAIN, NUMBNESS, TINGLING, SENSITIVITY TO THE TOUCH, THE SENSATION OF SWELLING, AND POOR BALANCE. A SUBSEQUENT LUMBAR MRI INDICATED RESTROLISTHESIS AT L3/L4. THE PHYSICIAN NOTED THAT THE CAGE LOOKS AS IF IT HAS LOST HEIGHT AND THEN MIGRATED. REVISION SURGERY WAS PERFORMED (B)(6) 2019. THE PHYSICIAN WAS UNABLE TO EXPLANT THE DEVICE AND INSTEAD PERFORMED ADJACENT SURGERY AT L3/L4 AND "TAMPED THE [DEVICE] BACK INTO THE DISC SPACE."

  Patient problems: Injury; Pain

  MAUDE report 8315418 ↗
• MalfunctionJun 26, 2017Mechanical Problem; Collapse; Mechanical Problem

  IT WAS REPORTED THAT; I WAS ALERTED TO A CAGE COLLAPSING ON (B)(6) 2017 FROM A CASE ON (B)(6) 2017.

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

  MAUDE report 6668453 ↗
• InjuryFeb 24, 2017Collapse; Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

  IT WAS REPORTED THAT; IMPLANT COLLAPSED AND RETROPULSED. REVISION SURGERY PERFORMED 4 WEEKS AFTER INITIAL. CAGE REMOVED AND NEW CAGE INSERTED.

  Patient problems: Injury; No Code Available

  MAUDE report 6358177 ↗
• InjuryDec 1, 2016Mechanical Problem; Collapse; Mechanical Problem; Device Slipped

  IT WAS REPORTED THAT THE GE COLLAPSED AND BACKED OUT INTO THE SPINAL CANAL.

  Patient problems: Injury; No Information

  MAUDE report 6138224 ↗
• MalfunctionSep 14, 2016Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem

  IT WAS REPORTED THAT; THE SURGEON POSITIONED THE IMPLANT AND WHEN BEGINNING TO EXPAND IT HE REPORTED HEARING TWO CLICKS AND LOSS OF RESISTANCE ON THE SYRINGE. ISSUE WAS NOTICED WHEN ATTEMPTING TO EXPAND THE IMPLANT. WE REMOVED THE IMPLANTS AND REPLACED IT WITH A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5951362 ↗
• MalfunctionJul 5, 2016Collapse

  IT WAS REPORTED THAT; USING AN INSERTER WHICH HAS BEEN KNOWN TO CORRECTLY EXPAND CAGE THEY WAY IT SHOULD, THE CAGE WAS IMPLANTED AT THE L4-L5 LEVEL, EXPANDED, AND RELEASED FROM THE INSERTER. VARIOUS FLUOROSCOPY IMAGES WERE TAKEN DURING THIS PROCESS. AFTER COMPLETION OF THE LEVEL, THE L5-S1 LEVEL WAS THEN PREPARED. UPON INSERTION OF THE CAGE AT THIS LEVEL, A FLURO SHOT WAS TAKEN TO CONFIRM PLACEMENT. IT WAS AT THIS TIME, APPROXIMATELY 10 MINUTES AFTER IT WAS INSERTED THAT WE NOTICED THAT THE CAGE HAD COLLAPSED BEYOND THE USUAL 1MM THAT MIGHT BE ACCEPTABLE TO THIS IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5769465 ↗
• MalfunctionJun 21, 2016Break; Collapse

  IT WAS REPORTED THAT; DURING SURGERY USING THE INSERTER; IT SLICED THE TUBING ON 2 SEPARATE TUBING SETS. ON THE THIRD SET, WE WERE CAREFUL NOT TO CUT THE TUBING. AFTER SUCCESSFULLY EXPANDING THE IMPLANT, IT COLLAPSED INTRAOPERATIVELY AFTER IT WAS RELEASED FROM THE INSERTER IN-SITU. UPDATE ((B)(6) 2016): UNEXPANDED CAGE WAS LEFT IMPLANTED. SURGEON WILL MONITOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5740192 ↗
• InjuryMay 18, 2016Collapse

  IT WAS REPORTED THAT THE CAGE COLLAPSED.

  Patient problems: No Information

  MAUDE report 5665046 ↗
• InjuryApr 11, 2016Disassembly; Collapse; Disassembly

  IT WAS REPORTED THAT; ORIGINAL DOS (B)(6) 2016, ON (B)(6) 2016 PATIENT PRESENTED X-RAYS TAKEN "POSSIBLE DEVICE COLLAPSED", REVISION SURGERY DONE ON (B)(6) 2016. DEVICE REMOVED, UNKNOWN WHETHER IT HAD COLLAPSED. IMPLANT FINALLY OBTAINED FROM RISK MANAGEMENT ON (B)(6) 2016. ADDITIONAL INFORMATION: PATIENT CAME FOR A FOLLOW UP VISIT 2 WEEKS AFTER THE SURGERY AND X-RAYS REVEALED VERTEBRAL BODY FRACTURE. THE IMPLANT WAS STILL EXPANDED. ACCORDING TO SALES REP, CAGE LOSS IN HEIGHT APPROXIMATELY 1 MM.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 5568662 ↗
• MalfunctionMar 9, 2016Adverse Event Without Identified Device or Use Problem; Leak/Splash; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED THAT THE CAGE ONLY EXPANDED A COUPLE OF MM THEN STOPPED. AS THE PLUNGER WAS TURNED, IT JUST KEPT SPINNING AND NOTHING HAPPENED. THE GREEN INDICATOR KEPT POPPING UP AND DOWN BUT ONLY TO GREEN. WHEN THE SURGEON REMOVED THE SYRINGE AND TRIED TO USE ANOTHER ONE, THE SYRINGE WAS STUCK (COULD NOT REMOVE FROM THE INSERTER). AFTER ABOUT TEN MINUTES OF MANIPULATION, THE SYRINGE WAS ABLE TO BE REMOVED. A SECOND SYRINGE WAS THEN PLACED ON THE INSERTER AND WHEN EXPANDING WATER WAS LEAKING OUT. THE O RING WAS FINE WHEN CHECKED, REMOVED THE O RING ANYWAY AND REPLACED WITH NEW ONE, AND PUT THE SYRINGE BACK AND SAME ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5490212 ↗