ACCULIF 305006Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327068030), received between Mar 22, 2016 and Jan 20, 2017 — classified as 3 injuries, 6 malfunctions.

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

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2017Mechanical Problem; Migration or Expulsion of Device; Unintended System Motion; Positioning Problem; Mechanical Problem; Migration or Expulsion of Device

  IT WAS REPORTED THAT ATL CAGE LOSS HEIGHT AND BACKED OUT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6267856 ↗
• InjuryJan 16, 2017Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem

  IT WAS REPORTED THAT; POST OP EVALUATION OF A PATIENT, SHOWS IMPLANT IS MIGRATING POSTERIORLY AND REVISION SURGERY IS REQUIRED. THE CAGE APPEARS TO STILL BE EXPANDED.

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

  MAUDE report 6254418 ↗
• MalfunctionNov 21, 2016Mechanical Problem; Mechanical Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE IMPLANT WOULDN'T EXPAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6118452 ↗
• MalfunctionOct 25, 2016Mechanical Problem; Mechanical Problem; Activation Failure

  IT WAS REPORTED THAT AN EXPANDABLE CAGE WOULD NOT EXPAND. NO LEAKAGE AT SYRINGE OR SYRINGE/INSERTER INTERFACE. NO PRESSURE OBSERVED AT INSERTER GAUGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6055205 ↗
• MalfunctionSep 23, 2016Mechanical Problem; Activation Failure; Mechanical Problem

  IT WAS REPORTED THAT; THE CAGE WAS INSERTED AND POSITIONED AND THE WOULD EXPAND AT ALL. CHECKED THE O-RINGS OF SYRINGE BODY AND PLUNGER BOTH WERE IN TACT, CHECKED THE TUBING ON BOTH ENDS AND NOTHING WAS DAMAGED, ALSO RETORQUED THE INTERBODY DOWN BEFORE EXPANDING A SECOND TIME AND THE CAGE WAS STILL UNABLE TO EXPAND. IMPLANT WAS LEFT UNEXPANDED, USED FIXATION (PEDICLE SCREW) AND PRESSED DOWN POSTERIORLY TO PREVENT IMPLANT MOVING. THERE ARE NO REPORT OF ANY REVISION SURGERIES, NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5972849 ↗
• MalfunctionSep 23, 2016Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem

  IT WAS REPORTED THAT; THE CAGE WAS INSERTED AND POSITIONED AND WOULD NOT EXPAND AT ALL. CHECKED THE O RINGS OF SYRINGE BODY AND PLUNGER BOTH WERE INTACT. CHECKED THE TUBING ON BOTH ENDS AND NOTHING WAS DAMAGED. ALSO RETORQUED THE INTERBODY DOWN BEFORE EXPANDING A SECOND TIME AND THE CAGE WAS STILL UNABLE TO EXPAND. IMPLANT WAS LEFT UNEXPANDED, USED FIXATION (PEDICLE SCREW) AND PRESSED DOWN POSTERIORLY TO PREVENT IMPLANT MOVING. THERE ARE NO REPORT OF ANY REVISION SURGERIES, NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5972773 ↗
• InjurySep 23, 2016Mechanical Problem; Activation Failure; Mechanical Problem

  IT WAS REPORTED THAT; THE CAGE WAS INSERTED AND POSITIONED AND THE WOULD EXPAND AT ALL. CHECKED THE O RINGS OF SYRINGE BODY AND PLUNGER BOTH WERE IN TACT. CHECKED THE TUBING ON BOTH ENDS AND NOTHING WAS DAMAGED. ALSO RETORQUED THE INTERBODY DOWN BEFORE EXPANDING A SECOND TIME AND THE CAGE WAS STILL UNABLE TO EXPAND. IMPLANT WAS LEFT UNEXPANDED, USED FIXATION (PEDICLE SCREW) AND PRESSED DOWN POSTERIORLY TO PREVENT IMPLANT MOVING. THERE ARE NO REPORT OF ANY REVISION SURGERIES, NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.. 4 LEVEL CASE, 3 OF CAGES EXPANDED 4TH CAGE DIDN'T EXPAND. SURGEON WAS SATISFIED WITH THE POSITION OF THIS CAGE, AS THE OTHER 3 CAGES EXPANDED (XRAYS WILL BE PROVIDED).

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

  MAUDE report 5972770 ↗
• MalfunctionSep 23, 2016Break; Mechanical Problem; Activation Failure; Mechanical Problem

  IT WAS REPORTED THAT; THE CAGE WAS INSERTED AND POSITIONED AND THE WOULD EXPAND AT ALL. CHECKED THE O RINGS OF SYRINGE BODY AND PLUNGER BOTH WERE IN TACT CHECKED THE TUBING ON BOTH ENDS AND NOTHING WAS DAMAGED ALSO RETORQUED THE INTERBODY DOWN BEFORE EXPANDING A SECOND TIME AND THE CAGE WAS STILL UNABLE TO EXPAND. EACH IMPLANT WAS LEFT UNEXPANDED, USED FIXATION (PEDICLE SCREW) AND PRESSED DOWN POSTERIORLY TO PREVENT IMPLANT MOVING. THERE ARE NO REPORT OF ANY REVISION SURGERIES, NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

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

  MAUDE report 5972737 ↗
• MalfunctionMar 22, 2016Mechanical Problem; Fluid/Blood Leak; Mechanical Problem; No Pressure

  IT WAS REPORTED THAT THE SURGEON WAS PLACING A CAGE IN AN L4-5 DISC SPACE. AFTER POSITIONING THE CAGE, THE SURGEON ATTACHED THE SYRINGE AND PLUNGER COMB AND BEGAN TURNING THE PLUNGER. UNDER FLUOR, HE COULD SEE THE CAGE RAISING WHILE THE PRESSURE GAUGE BEGAN RAISING. ONCE THE PRESSURE GAUGE REACHED THE GREEN TO YELLOW TRANSITION POINT THE SYRINGE SLOWLY LOST PRESSURE. NO FLUID WAS VISIBLE FROM ANY OF THE ATTACHMENT POINTS OUTSIDE OF THE WOUND. IT WAS NOTICED FLUID WAS LEAKING INTO THE WOUND. THE SYRINGE WAS REMOVED AND REFILLED WITH FLUID AND THE SURGEON RE ATTACHED THE SYRINGE AND ATTEMPTED TO RAISE THE CAGE AGAIN WITH THE SAME RESULTS. AT THIS POINT THE SURGEON ATTACHED THE ROTATOR TO THE ROTATOR ROD IN ATTEMPTS TO CHECK IF THE CAGE WAS STILL SECURELY ATTACHED TO THE INSERTER. ON A/P FLUORO INSPECTION IT APPEARED TO THE SURGEON THE CAGE WAS RAISING ASYMMETRIC AND THE LEADING EDGE OF THE CAGE DID NOT RAISE. SURGEON PROCEEDED WITH THE SURGERY DIS-ATTACHING THE INSERTER TO THE CAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5517417 ↗