REFLEX HYBRID 48694016Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540535115), received between Jul 6, 2018 and Oct 29, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration2
- Detachment of Device or Device Component1
Patient problems
- Discomfort1
- No Code Available1
- 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.
InjuryOct 29, 2022Migration; Migration
IT WAS REPORTED THAT REFLEX VARIABLE, SELF-TAPPING SCREW HAD DEVIATED BEYOND THE PLATE POSTOPERATIVELY. THE PATIENT COMPLAINED OF THROAT DISCOMFORT. REVISION SURGERY HAS NOT BEEN PLANNED, PATIENT WILL WEAR A CERVICAL COLLAR FOR 6 MONTHS BEFORE CONSIDERATION OF ADDITIONAL TREATMENT.
Patient problems: Discomfort
MAUDE report 15696138 ↗MalfunctionJul 6, 2018Detachment of Device or Device Component; Migration; Migration
IT WAS REPORTED THAT AN ANTERIOR CERVICAL PRESSURE FIXATION SURGERY FOR C3-6 WAS PERFORMED ON (B)(6) 2018. ON (B)(6) 2018, POST OPERATIVE X-RAY INDICATED THAT THE SCREW CAME OUT OF THE PLATE. SINCE THERE ARE NO SUBJECTIVE SYMPTOMS SUCH AS UNCOMFORTABLE FEELING IN THE PATIENT, THE PATIENT IS UNDER OBSERVATION.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7667676 ↗
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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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