AVIATOR 48824014Recalls & reported problems
Stryker Corporation · VARIABLE, SELF-DRILLING SCREW · Class 2 · Implant
All models of AVIATOR (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613252152606), received between Jul 19, 2018 and Oct 22, 2021 — classified as 8 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Migration” (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, 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
Device problems
- Migration7
- Unintended Movement4
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated2
- Material Deformation1
Patient problems
- Injury6
- Dysphagia/ Odynophagia2
- Failure of Implant2
- No Code Available2
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryJun 30, 2020Migration; Migration
IT WAS REPORTED THAT THE RETAINING SPRING OF AN AVIATOR ASSY THREE LEVEL PLATE BROKE AND TWO AVIATOR VARIABLE SELF DRILLING SCREWS BACKED OUT POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED AND THE TWO SCREWS HAVE BEEN REMOVED. THE PLATE REMAINS IMPLANTED. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.
Patient problems: Injury
MAUDE report 10215039 ↗InjuryJun 30, 2020Migration; Migration
IT WAS REPORTED THAT THE RETAINING SPRING OF AN AVIATOR ASSY THREE LEVEL PLATE BROKE AND TWO AVIATOR VARIABLE SELF DRILLING SCREWS BACKED OUT POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED AND THE TWO SCREWS HAVE BEEN REMOVED. THE PLATE REMAINS IMPLANTED. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWS.
Patient problems: Injury
MAUDE report 10214946 ↗InjuryJun 11, 2020Migration; Migration
IT WAS REPORTED THAT AN AVIATOR SCREW MIGRATED OUT OF A DEFORMED AVIATOR ASSY TWO LEVEL PLATE POST-OPERATIVELY. THE PATIENT WAS EXPERIENCING DYSPHAGIA AND THE SURGEON NOTICED THE SCREW HAD MIGRATED VIA X-RAY IMAGING. REVISION SURGERY WAS PERFORMED AND THE SCREW AND PLATE WERE REPLACED. THIS REPORT REPRESENTS THE SCREW.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 10142792 ↗InjuryMay 30, 2019Unintended Movement; Device Dislodged or Dislocated; Unintended Movement
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO C7 SCREWS BACKING OUT OF THE PLATE.
Patient problems: Injury
MAUDE report 8656863 ↗InjuryMay 30, 2019Unintended Movement; Device Dislodged or Dislocated; Unintended Movement
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO C7 SCREWS BACKING OUT OF THE PLATE.
Patient problems: Injury
MAUDE report 8656862 ↗MalfunctionSep 21, 2018Detachment of Device or Device Component; Migration; Migration
IT WAS REPORTED THAT UPON THE PATIENT'S FOLLOW UP VISIT, IT WAS DISCOVERED THAT THE IMPLANTS HAD STARTED TO DETACH OFF OF THE VERTEBRAE. IT IS UNKNOWN AT THIS TIME IF THE PATIENT WILL UNDERGO REVISION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7898561 ↗MalfunctionSep 21, 2018Detachment of Device or Device Component; Migration; Migration
IT WAS REPORTED THAT UPON THE PATIENT'S FOLLOW UP VISIT, IT WAS DISCOVERED THAT THE IMPLANTS HAD STARTED TO DETACH OFF OF THE VERTEBRAE. IT IS UNKNOWN AT THIS TIME IF THE PATIENT WILL UNDERGO REVISION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7898538 ↗InjuryJul 24, 2018Unintended Movement; Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE A PLATE AND SCREWS, AS THE SCREWS WERE BACKING OUT.
Patient problems: Failure of Implant; Injury; No Code Available
MAUDE report 7714231 ↗InjuryJul 19, 2018Material Deformation; Unintended Movement; Material Deformation
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE A PLATE AND SCREWS, AS THE SCREWS WERE BACKING OUT.
Patient problems: Failure of Implant; Injury; No Code Available
MAUDE report 7702659 ↗
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- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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