ACCULIFRecalls & reported problems across all models

We found 15 models of ACCULIF by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 76 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2016 and Jun 7, 2022 — classified as 24 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (39 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ACCULIF problems

ACCULIF models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ACCULIF 400008

  Intervertebral fusion device with bone graft, lumbar
  14 reports
• ACCULIF 305008

  Intervertebral fusion device with bone graft, lumbar
  10 reports
• ACCULIF 305006

  Intervertebral fusion device with bone graft, lumbar
  9 reports
• ACCULIF 800804

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  8 reports
• ACCULIF 400010

  Intervertebral fusion device with bone graft, lumbar
  7 reports
• ACCULIF 305010

  Intervertebral fusion device with bone graft, lumbar
  6 reports
• ACCULIF 905103

  Intervertebral fusion device with bone graft, lumbar
  5 reports
• ACCULIF 800044

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  5 reports
• ACCULIF 400006

  Intervertebral fusion device with bone graft, lumbar
  4 reports
• ACCULIF 800347

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• ACCULIF 800307

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• ACCULIF 800257

  Intervertebral fusion device with bone graft, lumbar
  1 report
• ACCULIF 800247

  Intervertebral fusion device with bone graft, lumbar
  1 report
• ACCULIF 800094

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• ACCULIF 800305

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent ACCULIF adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT OUTSIDE THE OR AN ACCULIF GRAFT INSERTION CANNULA WAS BENT AND UNUSABLE. THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT, THEREFORE, NO ADVERSE CONSEQUENCES TO ANY PATIENTS WERE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626880 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 28, 2017Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT; TOP OF PLUNGER BROKE OFF. UPDATE 12/19/2017: SURGEON PREFERS TO USE THIS INSTRUMENT WITH HIS TLIF PROCEDURES. SURGEON WAS NOT USING THIS INSTRUMENT WITH THE SAME BRAND IMPLANT.

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

  MAUDE report 7150790 ↗
• 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 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 ↗
• 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 23, 2017Device Expiration Issue

  IT WAS REPORTED THAT; WE ARE UNSURE BUT IT IS POSSIBLE THAT AN EXPIRED BOX OF TUBING WAS UTILIZED. THE SURGERY DATE WAS (B)(6) 2017 AND THE EXPIRATION DATE ON THE TUBING WAS 3/31/2017. THIS ITEM WAS NOT IN INVENTORY IN ORACLE TO RESERVE AS WE ONLY EVER RECEIVED 3 BOXES PER ORACLE AND THOSE 3 BOXES WERE PREVIOUSLY BILLED. WE ARE NOT SURE HOW/WHEN WE GOT THIS ITEM HOWEVER NOT IT WAS NOT TRANSACTED IN ORACLE TO US AND THEREFORE WAS NOT ON OUR EXPIRATION REPORT. SINCE THE ITEM WASN'T IN ORACLE TO TRANSACT AND SINCE THE SALES REPRESENTATIVE HAD 4 KITS, ONE OF WHICH BEING A LOANER, WE WAITED FOR THE KIT TO BE COUNTED UPON RETURN TO SEE IF ANOTHER LOT NUMBER WAS MISSING FROM THAT KIT (AND WOULD BE TRANSFERRED INTO OUR INVENTORY TO BILL) HOWEVER LOANERS DID NOT SHOW ANY OF THE ITEM MISSING FROM THEIR LOANER KIT. ADDITIONALLY, WE ASKED THE MAIN SALES REP AT THE ACCOUNT TO DO AN INVENTORY COUNT TO SEE WHAT LOT NUMBERS WERE IN THE OTHER KITS IN HIS POSSESSION TO SEE IF ANOTHER LOT NUMBER WAS MISSING AND MAY HAVE BEEN UTILIZED. SINCE THE STICKERS WERE NOT ON USAGE SHEET, ON (B)(6), WHEN WE ASKED THE SALES ASSOCIATE THAT COVERED THE SURGERY, HOW HE DETERMINED THE LOT NUMBERS STATED ON THE SURGE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6586502 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 10, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; THREE OF THE GREEN RINGS BROKE DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6239367 ↗
• MalfunctionJan 10, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; THREE OF THE GREEN RINGS BROKE DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6239295 ↗
• 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 ↗

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