REFLEX HYBRID 48651234Recalls & reported problems
Stryker Corporation · TWO-LEVEL PLATE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540534828), received between Feb 9, 2016 and Feb 17, 2017 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Mechanical Problem3
- Detachment of Device or Device Component1
- Device Slipped1
- Malposition of Device1
Patient problems
- Injury3
- Failure of Implant1
- 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.
InjuryFeb 17, 2017Mechanical Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT; (B)(6) 2016, IMPLANTED FOUR SCREWS AND THE 2 LEVEL PLATE ON C3-5. ON (B)(6) 2017, IT WAS INFORMED THE SCREW OF C5 RIGHT WAS OUT. ON (B)(6) 2017 IT WAS SURGICAL TREATMENT FOR SCREW OUT.
Patient problems: Injury; No Code Available
MAUDE report 6340632 ↗InjuryMar 21, 2016Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Malposition of Device; Device Dislodged or Dislocated
IT WAS REPORTED THAT; THE PATIENT DID THE ANTERIOR CERVICAL FUSION SURGERY IN (B)(6) 2016; WHEN HE DID EXAMINATION IN (B)(6) 2016, THE DOCTOR FOUND THE SCREW EXITED FROM THE PLATE.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 5514956 ↗InjuryFeb 9, 2016Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Slipped; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD AN IMPLANT FAILURE AND SUBSIDENCE OF CERVICAL GRAFTS. THE SCREWS ON THE CERVICAL PLATE BACKED OUT OF THE SUPPOSEDLY LOCKED. THE DEVICE WAS REMOVED AND REPLACED WITH NON-STRYKER CERVICAL PLATE.
Patient problems: Failure of Implant; Injury
MAUDE report 5419792 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Elegance® Anterior Cervical Plate 53430353Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430108Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430240Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430236Clariance · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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