REFLEX HYBRID 48651232Recalls & reported problems
Stryker Corporation · TWO-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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540534811), received between Feb 25, 2020 and Aug 5, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
- Migration1
Patient problems
- Abscess1
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- Paralysis1
- Perforation of Esophagus1
- Pneumonia1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
A PHYSICIAN REPORTED THAT THE SECURING MECHANISM OF A REFLEX HYBRID TWO-LEVEL PLATE FAILED AND TWO REFLEX HYBRID FIXED ANGLE BONE SCREWS PLACED AT C7 BACKED-OUT; THE ORDER OF EVENTS IS NOT KNOWN AT THIS TIME. THE PATIENT HAS BEEN REVISED. THIS REPORT REPRESENTS THE PLATE.
Patient problems: Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 10367068 ↗InjuryFeb 25, 2020Migration; Migration
A REPRESENTATIVE FOR THE PATIENT REPORTED THAT A REFLEX-HYBRID 2 LEVEL ACP PLATE MIGRATED APPROXIMATELY SIX YEARS AFTER IMPLANTATION CAUSING AN ESOPHAGEAL PERFORATION WHICH LEAD TO AN INFECTION, ABSCESS, AND PNEUMONIA. THE PATIENT REPORTEDLY UNDERWENT A REVISION SURGERY, DURING WHICH TIME THEY EXPERIENCED PARALYSIS OF THE VOCAL CORD AND LEFT SIDE OF THE NECK. IT IS ADDITIONALLY REPORTED THAT THE INFECTION LEAD TO OSTEOMYELITIS FOR WHICH THE PATIENT UNDERWENT ADDITIONAL SURGERIES.
Patient problems: Abscess; Paralysis; Perforation of Esophagus; Pneumonia; Unspecified Infection
MAUDE report 9749823 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page