REFLEX HYBRID 48651472Recalls & reported problems
Stryker Corporation · FOUR-LEVEL PLATE · Class 2 · Implant
All models of REFLEX HYBRID (34)
Data updated Oct 16, 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 04546540535016), received between Dec 13, 2017 and May 7, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Fracture1
- Material Deformation1
- Material Protrusion/Extrusion1
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.
MalfunctionMay 7, 2021Fracture; Material Deformation; Fracture; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT INSERTION OF A 4.0 MM REFLEX SCREW AT LEFT C4 WOULD NOT FINAL LOCK. WHILE REMOVING THE SCREW, THE SECURING MECHANISM OF A FOUR-LEVEL REFLEX HYBRID PLATE FRACTURED. ALL SCREWS AND THE PLATE WERE REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FOUR-LEVEL REFLEX-HYBRID PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11791137 ↗MalfunctionDec 13, 2017Device Operates Differently Than Expected; Material Protrusion/Extrusion; Device Operates Differently Than Expected
IT WAS REPORTED THAT; AN ACDF C3-7 WAS PERFORMED. THE SURGEON FINAL TIGHTENING THE RIGHT C5 SCREW AND THE LOCKING RING PUSHED OUT AND STUCK OUT FROM THE PLATE. SURGEON REMOVED THE SCREW AND PULLED THE LOCKING RING FROM THE PLATE OUT OF THE SURGICAL SITE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7112611 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- 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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