REFLEX HYBRID 48651114Recalls & reported problems
Stryker Corporation · ONE-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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540534729), received between Jul 25, 2016 and Jun 21, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Operates Differently Than Expected1
- Device Slipped1
- Difficult to Remove1
- Fracture1
- Material Deformation1
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LOCKING RING OF A REFLEX HYBRID 2 PLATE DISENGAGED FROM THE PLATE INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 3 MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12037233 ↗MalfunctionJan 17, 2018Difficult to Remove; Device Operates Differently Than Expected; Difficult to Remove
IT WAS REPORTED THAT: THE PATIENT SUPINE, THE CONVENTIONAL SURGICAL DISINFECTION SHOP TOWELS, FULL CLEAR SURGICAL FIELD EXPOSURE, REGULAR LINE OF ANTERIOR CERVICAL DECOMPRESSION, INTO THE INTERVERTEBRAL FUSION, DID NOT LOCK, PERSPECTIVE, STEEL PLATE POSITION, THEN REMOVE THE SCREW ORDER, BUT FOUND THAT SCREW CAN'T TAKE OUT, CAN ONLY TAKE OUT AS A WHOLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7199852 ↗InjuryJul 25, 2016Device Slipped; Material Deformation; Material Deformation
IT WAS REPORTED THAT; ON (B)(6) 2014, PRIMARY SURGERY WAS PERFORMED. AFTER THAT, A SCREW BACKOUT WAS FOUND IN REGULAR POST OP VISIT. THEN AN EXTRACTION SURGERY OF ALL THE IMPLANT WAS PERFORMED ON (B)(6) 2016.
Patient problems: Injury; No Code Available
MAUDE report 5821008 ↗
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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