AVIATOR 48811345Recalls & reported problems
Stryker Corporation · THREE-LEVEL ANTERIOR PLATE · Class 2 · Implant
All models of AVIATOR (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252152286), received between Apr 13, 2016 and Nov 21, 2017 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Mechanical Problem2
- Migration or Expulsion of Device2
- Break1
- Device Operates Differently Than Expected1
- Material Protrusion/Extrusion1
Patient problems
- Injury2
- No Known Impact Or Consequence To Patient2
- Failure of Implant1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2017Break; Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device
IT WAS REPORTED THAT; HARDWARE REMOVAL OF ACDF PLATE. 3 LVL CONSTRUCT. 8 TOTAL SCREWS. ALLOGRAFT SPACER IN THE DISK SPACE. THE BOTTOM SCREW AT C6 HAD BROKEN THE SPRING BAR ON THE CERVICAL PLATE AND CAUSED THE SCREW TO BACK OUT. SURGEON REMOVED THAT PLATE AND SCREWS IN ITS ENTIRETY. THE PATIENT DOESN'T SEEM TO BE AFFECTED.
Patient problems: Failure of Implant; Injury
MAUDE report 7048152 ↗InjuryJan 27, 2017Mechanical Problem; Migration or Expulsion of Device; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT A CERVICAL SCREW CAME OUT OF THE PLATE AND WENT THROUGH THE PATIENTS TRACHEA AND WAS SPIT OUT BY THE PATIENT. SURGERY WAS DONE TO REMOVE THE SECOND SCREW.
Patient problems: Injury; No Information
MAUDE report 6282663 ↗MalfunctionJul 28, 2016Material Protrusion/Extrusion
IT WAS REPORTED THAT; SURGEON INFORMED REP THAT WING OF AVIATOR PLATE PROTRUDING OUTWARD. SURGEON USED COKER INSTRUMENT TO BREAK OFF WING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5829174 ↗MalfunctionApr 13, 2016Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem
IT WAS REPORTED THAT WHEN THE SURGEON WAS TRYING TO FINAL LOCK THE PLATE, ONE OF THE LOCKING MECHANISMS WOULDN'T PROPERLY LOCK. IT WAS FREE SPINNING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5574747 ↗
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- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- 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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