AVIATORRecalls & reported problems across all models
Stryker Corporation · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 134
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls
- 0
We found 36 models of AVIATOR by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 134 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2016 and May 10, 2024 — classified as 48 injuries, 86 malfunctions.
The most frequently reported specific device problem is “Fracture” (51 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
Reports received per month, all models
Most reported AVIATOR problems
Device problems
- Fracture51
- Break45
- Material Deformation33
- Device Dislodged or Dislocated22
- Material Integrity Problem17
- Migration15
- Mechanical Problem12
- Detachment of Device or Device Component10
Patient problems
- No Known Impact Or Consequence To Patient67
- Injury35
- No Consequences Or Impact To Patient20
- No Clinical Signs, Symptoms or Conditions18
- No Code Available17
- Discomfort6
- Failure of Implant5
- No Information5
AVIATOR models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AVIATOR 48824014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY10 reports
- AVIATOR 48811234APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY9 reports
- AVIATOR 48770410ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- AVIATOR 48770820ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- AVIATOR 48811114APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY8 reports
- AVIATOR 48811228APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY8 reports
- AVIATOR 48824016APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY7 reports
- AVIATOR 48811232APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY6 reports
- AVIATOR 48844016APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY6 reports
- AVIATOR 48811226APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- AVIATOR 48811230APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- AVIATOR 48811345APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- AVIATOR 48811348APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- AVIATOR 48824012APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- AVIATOR 48844014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- AVIATOR 48811112APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- AVIATOR 48811354APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- AVIATOR 48811357APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- AVIATOR 48814014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- AVIATOR 48770905BORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- AVIATOR 48811118APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- AVIATOR 48811224APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- AVIATOR 48811339APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- AVIATOR 48834018APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- AVIATOR 48770800ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- AVIATOR 48811116APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48811120APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48811237APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48811240APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48811342APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48811472APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48814016APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48834514APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48834518APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48844018APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- AVIATOR 48770655ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent AVIATOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2024Fracture; Difficult to Insert; Fracture; Difficult to Insert
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING MECHANISM OF AN AVIATOR ASSY TWO LEVEL PLATE FAILED TO LOCK COMPLETELY AND WAS IMPLANTED IN THE PATIENT WITH A PARTIAL LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19290465 ↗InjuryFeb 2, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS THE MIGRATION OF AN AVIATOR VARIABLE SELF-DRILLING SCREW AT LEFT-SIDE C7. DURING SURGERY, IT WAS DISCOVERED THAT THE LOCKING WING OF THE AVIATOR THREE-LEVEL PLATE WAS FRACTURED AT THAT SAME LEVEL. THIS REPORT CAPTURES THE AVIATOR THREE-LEVEL PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18631238 ↗MalfunctionJul 6, 2022Mechanical Jam; Mechanical Jam
A COMPANY REPRESENTATIVE REPORTED THAT AN AVIATOR PUNCH AWL WAS JAMMED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14936135 ↗MalfunctionJun 10, 2022Fracture; Fracture
IT WAS REPORTED THAT AN AVIATOR TEMPORARY FIXATION PIN SNAPPED IN HALF DURING INSERTION INTO THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14658355 ↗MalfunctionApr 29, 2022Fracture; Fracture
IT WAS REPORTED THAT THE LOCKING MECHANISM OF AN AVIATOR ONE LEVEL PLATE DETACHED POST-OPERATIVELY CAUSING AN AVIATOR SCREW TO MIGRATE. THE DEVICES REMAIN IMPLANTED, REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14255468 ↗MalfunctionApr 19, 2022Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE HEADS OF TWO AVIATOR FIXED SELF-DRILLING SCREWS FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14141198 ↗MalfunctionApr 19, 2022Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE HEADS OF TWO AVIATOR FIXED SELF-DRILLING SCREWS FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14141194 ↗MalfunctionApr 12, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF AN AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER BROKE INTRA-OPERATIVELY DURING SCREW REMOVAL. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14090849 ↗MalfunctionFeb 17, 2022Fracture; Fracture
IT WAS REPORTED THAT THE SPRING BAR OF AN AVIATOR TWO LEVEL PLATE FRACTURED AND A SCREW MIGRATED POST-OPERATIVELY. THE PATIENT WILL BE MONITORED AND REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13549032 ↗MalfunctionDec 1, 2021Fracture; Difficult to Insert; Fracture; Difficult to Insert
IT WAS REPORTED THAT PART OF AN AVIATOR FIXED SELF TAPPING SCREW SHEARED OFF DURING SURGERY. SURGERY WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12909952 ↗MalfunctionNov 2, 2021Fracture; Material Fragmentation; Insufficient Device Problem Information; Fracture; Material Fragmentation; Insufficient Device Problem Information
IT WAS REPORTED THAT THE THREADING OF AN AVIATOR SELF TAPPING SCREW FRACTURED INTRA-OPERATIVELY. A METAL SHARD FROM THE SCREW WAS LOCATED AND REMOVED FROM THE SURGICAL SITE BEFORE PROCEDURE CLOSE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12737644 ↗InjuryOct 22, 2021Migration; Migration
IT WAS REPORTED THAT WHILE EXPLANTING AN AVIATOR PLATE DURING A REVISION ACDF PROCEDURE, APPROXIMATELY 3 YEARS AFTER INDEX SURGERY, THE LOCKING MECHANISM OF THE PLATE WAS OBSERVED TO BE BROKEN. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON ALSO STATES THAT ONE AVIATOR VARIABLE SCREW HAD MIGRATED AT C6, THE LEVEL WHERE THE LOCKING MECHANISM OF THE PLATE FRACTURED. THE PATIENT WAS REVISED TO REMOVE THE CONSTRUCT. THIS RECORD CAPTURES THE MIGRATED AVIATOR VARIABLE SCREW.
Patient problems: Dysphagia/ Odynophagia; No Clinical Signs, Symptoms or Conditions
MAUDE report 12684033 ↗InjurySep 15, 2021Fracture; Fracture
IT WAS REPORTED THAT WHILE EXPLANTING AN AVIATOR PLATE DURING A REVISION ACDF PROCEDURE, APPROXIMATELY 3 YEARS AFTER INDEX SURGERY, THE LOCKING MECHANISM OF THE PLATE WAS OBSERVED TO BE BROKEN. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON ALSO STATES THAT ONE AVIATOR VARIABLE SCREW HAD MIGRATED AT C6, THE LEVEL WHERE THE LOCKING MECHANISM OF THE PLATE FRACTURED. THE PATIENT WAS REVISED TO REMOVE THE CONSTRUCT. THIS RECORD CAPTURES THE FRACTURED LOCKING MECHANISM OF THE AVIATOR PLATE.
Patient problems: Dysphagia/ Odynophagia; No Clinical Signs, Symptoms or Conditions
MAUDE report 12477518 ↗MalfunctionSep 9, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF AN AVIATOR TEMPORARY FIXATION PIN FRACTURED INTRA-OPERATIVELY, DURING INSERTION AT C6. THE FRACTURED COMPONENT WAS LEFT IN THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12450162 ↗MalfunctionMay 12, 2021Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
IT WAS REPORTED THAT DURING INTRA-OPERATIVE FINAL TIGHTENING, 2 AVIATOR RETAINING SCREWDRIVERS COULD NOT 'DRIVE THE SCREW INTO THE POCKING MECHANISM ON THE PLATE'. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 20 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE SECOND OF THE TWO SCREWDRIVERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11815518 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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