AVIATOR 48811339Recalls & reported problems
Stryker Corporation · THREE-LEVEL ANTERIOR PLATE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252152262), received between Jul 8, 2016 and Feb 1, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (2 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
Device problems
- Material Deformation2
- Bent1
- Device Operates Differently Than Expected1
Patient problems
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 1, 2020Material Deformation; Material Deformation
IT WAS CONFIRMED VIA X-RAY THAT AN AVIATOR SCREW BACKED-OUT OF AN AVIATOR 3-LEVEL PLATE WITH A DEFORMED LOCKING MECHANISM POST-OPERATIVELY. THE PATIENT HAS BEEN REVISED, THE SCREW WAS REMOVED WHILE THE PLATE REMAINS IMPLANTED. THIS RECORD REPRESENTS THE PLATE.
Patient problems: Injury
MAUDE report 9656247 ↗MalfunctionJul 8, 2016Bent; Device Operates Differently Than Expected; Material Deformation; Material Deformation
IT WAS REPORTED THAT; THE LOCKING WING ON PLATE BENT UPON SCREW INSERTION DUE TO WING OVERHANGING THE SCREW HOLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5780352 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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