Aero-CRecalls & reported problems across all models

We found 8 models of Aero-C by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2016 and Jun 11, 2021 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 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 Aero-C problems

Aero-C models

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

• Aero-C 48892066

  Intervertebral fusion device with bone graft, cervical
  9 reports
• Aero-C 48892050

  Intervertebral fusion device with bone graft, cervical
  3 reports
• Aero-C 48894066

  Intervertebral fusion device with bone graft, cervical
  3 reports
• Aero-C 48892076

  Intervertebral fusion device with bone graft, cervical
  2 reports
• Aero-C 48896066

  Intervertebral fusion device with bone graft, cervical
  2 reports
• Aero-C 48894076

  Intervertebral fusion device with bone graft, cervical
  2 reports
• Aero-C 48890002

  Intervertebral fusion device with bone graft, cervical
  1 report
• Aero-C 48894050

  Intervertebral fusion device with bone graft, cervical
  1 report

Recent Aero-C adverse event reports

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

• MalfunctionJun 11, 2021Migration; Migration

  IT WAS REPORTED THAT THE BLADE OF AN AERO C CAGE BROKE OFF AND TRANSLATED POSTERIORLY AT C3 POST-OPERATIVELY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES AT THIS TIME. REVISION SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987259 ↗
• MalfunctionJun 9, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE IMPLANT PLACEMENT, THE BLADES OF THREE AERO C CAGES WERE NOT ENGAGING PROPERLY. AT C5/6 THE BLADES OF TWO CAGES WOULD NOT SEAR, AND AT C6/7 THE SUPERIOR BLADE PLUNGED DEEPER THAN EXPECTED. ALL THREE CAGES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVELY AVAILABLE IMPLANTS. THIS RECORD CAPTURES THE FIRST OF THE THREE CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971307 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE IMPLANT PLACEMENT, THE BLADES OF THREE AERO C CAGES WERE NOT ENGAGING PROPERLY. AT C5/6 THE BLADES OF TWO CAGES WOULD NOT SEAR, AND AT C6/7 THE SUPERIOR BLADE PLUNGED DEEPER THAN EXPECTED. ALL THREE CAGES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVELY AVAILABLE IMPLANTS. THIS RECORD CAPTURES THE THIRD OF THE THREE CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971273 ↗
• MalfunctionJun 9, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE IMPLANT PLACEMENT, THE BLADES OF THREE AERO C CAGES WERE NOT ENGAGING PROPERLY. AT C5/6 THE BLADES OF TWO CAGES WOULD NOT SEAR, AND AT C6/7 THE SUPERIOR BLADE PLUNGED DEEPER THAN EXPECTED. ALL THREE CAGES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVELY AVAILABLE IMPLANTS. THIS RECORD CAPTURES THE SECOND OF THE THREE CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971190 ↗
• MalfunctionJun 4, 2021Migration; Migration

  IT WAS REPORTED THAT AN AERO-C PEEK CAGE AT C3/4 MIGRATED POST-OPERATIVELY. FUSION HAS BEEN ACHIEVED. REVISION SURGERY IS NOT SCHEDULED OR PLANNED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 11939187 ↗
• InjuryMar 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SUPERIOR ANCHOR OF AN AERO C CAGE AT C5 BROKE AND MIGRATED THREE YEARS POST-OPERATIVELY. THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE MIGRATED ANCHOR WAS REMOVED BUT THE CAGE AND THE INFERIOR ANCHOR WERE LEFT IN PLACE BECAUSE THE PATIENT HAD ACHIEVED FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399190 ↗
• MalfunctionJun 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT AN AERO C CAGE ANCHOR DISENGAGED INTRA-OPERATIVELY. AN X-RAY WAS TAKEN DURING THE PROCEDURE TO CONFIRM THE POSITION OF THE AERO-C ANCHOR AND IT WAS DISCOVERED THAT THE ANCHOR WAS IMPLANTED BEYOND THE POSTERIOR END OF THE AERO C CAGE. THE CAGE AND THE ANCHOR WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10182033 ↗
• InjuryMar 14, 2020Material Deformation; Separation Problem; Material Deformation; Separation Problem

  STRYKER REPRESENTATIVE REPORTED THAT WHEN THE SURGEON MALLETED AN AERO-C CAGE 5MM INTERBODY DEVICE, 12DX14W PARALLEL INTO THE DISC SPACE, THE BLADES WERE OUTSIDE OF THE IMPLANT AND THE IMPLANT BENT. SURGERY WAS COMPLETED WITH A TWO HOUR DELAY.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9832644 ↗
• MalfunctionMar 1, 2019Malposition of Device; Migration; Migration

  IT WAS REPORTED THAT THE CAGE STARTED BACKING OUT POST-OPERATIVELY. IMPLANT IS STILL IN THE PATIENT AND EXPERIENCED SLIGHT PAIN AND SLIGHT TINGLING IN FINGER. PER THE COMMUNICATION WITH SALES REP., X- RAY IMAGE REVIEW WHICH WAS TAKEN (B)(6) 2019 REVEALED THAT CAGE( PIN) HAD NOT BACKED OUT FURTHER. CURRENTLY, NO REVISION SURGERY HAS BEEN PLANNED.

  Patient problems: Pain; Tingling

  MAUDE report 8383672 ↗
• MalfunctionSep 11, 2018Break

  IT IS REPORTED THAT A PILOT CUTTER BROKE AND ANCHOR BLADE PASSED THOUGH THE CAGE AS A RESULT OF DISTRACTION PIN HITTING THE ANCHOR BLADE. THE CAGE REMAIN IMPLANTED. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7866532 ↗
• MalfunctionFeb 5, 2018Break; Fracture; Improper or Incorrect Procedure or Method; Fracture

  DURING THE IMPLANTING OF A CAGE, THE SURGEON MENTIONED THAT HE ANGLED THE INSERTER SLIGHTLY BOTH CEPHALAD AND CAUDAL IN ORDER TO TRY CLOSE A FISH MOUTHING DISC SPACE. THIS STRATEGY WAS IMPLEMENTED IN THE HOPES OF CATCHING MORE BONE AND EFFECTIVELY SEATING THE ANCHORS IN TO AS MUCH BONE AS POSSIBLE. THE REPRESENTATIVE WAS MADE AWARE OF THIS STRATEGY POST OPERATIVELY. THE SURGEON DOES UNDERSTAND THE CORRECT ON LABEL USE OF THE PRODUCT BUT FELT THIS ADDITIONAL TECHNIQUE WAS NECESSARY WITH THIS PARTICULAR PATIENT. WHEN THE ANCHORS WERE INSERTED, THEY ENTERED THE BONE BUT PULLED THEMSELVES OUT OF THE CAGE BECAUSE OF THE INCREASED ANGLE AND ADDITIONAL PRESSURE, BOTH BREAKING THE CAGE AND BENDING THE TITANIUM JACKET. WHEN THE SURGEON DEEMED THE IMPLANT WAS DAMAGED, A HYBRID PLATE AND SCREWS WERE IMPLANTED OVER THE CONSTRUCT AT THE SAME LEVEL (C4-C5) IN ORDER TO ENSURE ACHIEVED PROPER FIXATION OF THE SEGMENT AND A SUCCESSFUL FUSION AT THE CORRECT SURGICAL LEVEL. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WERE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGEON WAS CONCERNED ABOUT THE STIFFNESS OF THE CONNECTION BETWEEN THE IMPLANT AND THE INSERTER. HOWEVER, UPON FOLLOW UP,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7242123 ↗
• MalfunctionOct 30, 2017Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; THE CUTTER WOULD NOT PENETRATE BONE. IN RESPONSE THE CAGE KEPT GETTING FORCED OUT OF THE DISC SPACE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6989415 ↗
• MalfunctionAug 7, 2017Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem; Failure to Advance

  IT WAS REPORTED THAT; ANCHOR WOULD NOT FULLY INSERT INTO CAGE. BOTH THE GUIDED AND FREEHAND TAMPS WERE IMPACTED FORCEFULLY AGAINST THE PARTIALLY INSERTED ANCHOR, BUT THE ANCHOR WOULD NOT PROGRESS FURTHER. THE END OF THE ANCHOR REMAINS PROUD BY APPROXIMATELY 1-2MM. THERE WAS A SURGICAL DELAY OF 5 MINUTES ASSOCIATED WITH SEVERAL ATTEMPTS TO IMPACT THE ANCHOR USING BOTH TYPES OF TAMPS IN THE SET. THE SURGEON ULTIMATELY DECIDED TO LEAVE THE CAGE WITH THE ANCHOR REMAINING PROUD. FLUOROSCOPIC IMAGE OF IMPLANTED CAGE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6772610 ↗
• MalfunctionJun 30, 2017Mechanical Problem; Mechanical Problem; Migration or Expulsion of Device; Retraction Problem

  IT WAS REPORTED THAT; THE BLADE WOULD NOT GO INTO THE BODY AND CAGE KEPT MIGRATING INTERIORLY. CAGE WAS LEFT IMPLANTED VERY ANTERIOR AND HAD TO USE EXCESSIVE MALLETING. 2 ANCHORS WERE IMPLANTED. AFTER EXCESSIVE FORCE THE BLADE WAS FINALLY IMPLANTED. ADVERSE CONSEQUENCES REMAINS TO BE SEEN. PATIENT HAD HARD BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6681579 ↗
• MalfunctionMar 29, 2017Disassembly; Difficult to Insert; Disassembly

  IT WAS REPORTED THAT; THE ANCHOR OF THE CAGE WOULD NOT FULLY INSERT INTO BONE. THE PILOT CUTTER WOULD NOT SEAT ALL THE WAY INTO BONE EITHER. THE SURGEON ATTEMPTED TO DRIVE THE CUTTER SEVERAL TIMES AND WE TRIED MULTIPLE DIFFERENT PILOT CUTTERS. THEN HE ATTEMPTED TO DRIVE THE ANCHOR INTO VERTEBRAL BODY AND IT STOPPED AFTER DRIVING THROUGH BONE APPROXIMATELY 85% OF THE WAY. WE ATTEMPTED SEVERAL DIFFERENT TAMPS AS WELL AS THE FREE HAND TAMP. AFTER TRYING FOR 5-10 MINUTES THE SURGEON WAS NOT WILLING TO APPLY ANY MORE FORCE VIA MALLETING THE ANCHOR. THE SURGEON WAS MALLETING AT A FORCE GREATER THAN NORMAL FOR CERVICAL IMPLANT PLACEMENT. THE BLADE WAS LEFT WITHOUT BEING FULLY INSERTED. THE ASSOCIATED SURGICAL DELAY WAS 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6443458 ↗

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