REFLEX HYBRID 48694012Recalls & reported problems
Stryker Corporation · VARIABLE, SELF-TAPPING SCREW · Class 2 · Implant
All models of REFLEX HYBRID (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540535092), received between Jul 1, 2016 and Jul 1, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Material Fragmentation1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2016Material Fragmentation; Difficult to Insert; Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT; DOCTOR WAS DOING A C3-4 ACDF USING A 16MM PLATE WITH SCREWS. APPROX 3 SCREWS WERE SUCCESSFULLY INSERTED, THEN HE WAS UNABLE TO GET THE 4TH SCREW TO FULLY LOCK. THE SCREW WAS REMOVED, THE DOC WAS REMINDED OF THE ANGULATION PARAMETERS OF THE PLATE, AND A NEW PATH WAS DRILLED USING A 12MM DRILL AND A VARIABLE SINGLE BARREL GUIDE. THE DOC THEN TRIED TO INSERT A SCREW, BUT WAS UNABLE TO GET IT TO LOCK. WHEN HE TOOK THE SCREW OUT, HE NOTICED TWO METAL SHARDS NEAR THE SCREW INSERTION POINT. HE REMOVED THE METAL PIECES, LEFT THE SCREW OUT, AND COMPLETED THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5766249 ↗
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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
- 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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