AVIATOR 48824012Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252152590), received between Jul 11, 2016 and Apr 17, 2019 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Appropriate Device Problem Term/Code Not Available1
- Component Incompatible1
- Detachment of Device or Device Component1
- Device Slipped1
Patient problems
- Injury4
- Pain3
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2019Device Dislodged or Dislocated
ON (B)(6) 2019, THE REFLEX HYBRID SYSTEM WAS IMPLANTED WITH NO KNOWN ISSUE. ON (B)(6) 2019, IT WAS DISCOVERED THAT INCOMPATIBLE SCREWS WERE USED WITH THE PLATE, THE SURGEON WAS NOTIFIED. DURING A POST-OPERATIVE X-RAY, THE SURGEON NOTED THAT THE SCREWS AND PLATE WERE BACKING OUT. THE PATIENT WAS EXPERIENCING SOME PAIN AND UNDERWENT REVISION SURGERY ON (B)(6) 2019 TO REPLACE THE PLATE AND SCREWS.
Patient problems: Injury; Pain
MAUDE report 8522916 ↗InjuryApr 17, 2019Component Incompatible; Detachment of Device or Device Component; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated
ON (B)(6) 2019, THE REFLEX HYBRID SYSTEM WAS IMPLANTED WITH NO KNOWN ISSUE. ON (B)(6) 2019, IT WAS DISCOVERED THAT INCOMPATIBLE SCREWS WERE USED WITH THE PLATE, THE SURGEON WAS NOTIFIED. DURING A POST-OPERATIVE X-RAY, THE SURGEON NOTED THAT THE SCREWS AND PLATE WERE BACKING OUT. THE PATIENT WAS EXPERIENCING SOME PAIN AND UNDERWENT REVISION SURGERY ON (B)(6) 2019 TO REPLACE THE PLATE AND SCREWS.
Patient problems: Injury; Pain
MAUDE report 8522914 ↗InjuryApr 17, 2019Device Dislodged or Dislocated
ON (B)(6) 2019, THE REFLEX HYBRID SYSTEM WAS IMPLANTED WITH NO KNOWN ISSUE. ON (B)(6) 2019, IT WAS DISCOVERED THAT INCOMPATIBLE SCREWS WERE USED WITH THE PLATE, THE SURGEON WAS NOTIFIED. DURING A POST-OPERATIVE X-RAY, THE SURGEON NOTED THAT THE SCREWS AND PLATE WERE BACKING OUT. THE PATIENT WAS EXPERIENCING SOME PAIN AND UNDERWENT REVISION SURGERY ON (B)(6) 2019 TO REPLACE THE PLATE AND SCREWS.
Patient problems: Injury; Pain
MAUDE report 8522832 ↗InjuryJul 11, 2016Device Slipped; Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT; SCREWS BACKED THROUGH THE LOCKING MECHANISM INTO THE PATIENTS VOCAL CHORDS
Patient problems: Injury; No Code Available
MAUDE report 5783600 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- 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
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
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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