REFLEX HYBRID 48651354Recalls & reported problems
Stryker Corporation · THREE-LEVEL PLATE · Class 2 · Implant
All models of REFLEX HYBRID (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540534927), received between Apr 11, 2018 and Jun 29, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Bent” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Bent1
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Fracture1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionJun 29, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem
IT WAS REPORTED THAT THE REFLEX HYBRID VARIABLE SCREW OF THE REFLEX HYBRID CERVICAL PLATE HAS PASSED OVER THE PLATE, BREAKING THE SAFETY RING. THE EVENT WAS NOTICED DURING A POST-OPERATIVE CT SCAN. NO ADVERSE CONSEQUENCES WERE REPORTED AT THIS TIME. THERE ARE NO PLANS FOR REVISION AT THIS TIME. THIS RECORD CAPTURES THE REFLEX HYBRID CERVICAL PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12084328 ↗MalfunctionApr 11, 2018Detachment of Device or Device Component; Bent; Detachment Of Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SURGEON NOTICED THAT THE RING ON THE PLATE BENT, OPENED UP, AND CAME DETACHED FROM THE PLATE ITSELF. THE SCREW WAS ABORTED AND THE SURGEON PROCEEDED WITH THE PROCEDURE WITHOUT USING THAT HOLE FOR FIXATION. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7423449 ↗
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- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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