REFLEX HYBRID 48651112Recalls & reported problems
Stryker Corporation · ONE-LEVEL PLATE · Class 2 · Implant
All models of REFLEX HYBRID (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540534712), received between Apr 17, 2019 and Apr 17, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Injury1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2019Device Dislodged or Dislocated
ON (B)(6) 2019, THE REFLEX HYBRID SYSTEM WAS IMPLANTED WITH NO KNOWN ISSUE. ON (B)(6) 2019, IT WAS DISCOVERED THAT INCOMPATIBLE SCREWS WERE USED WITH THE PLATE, THE SURGEON WAS NOTIFIED. DURING A POST-OPERATIVE X-RAY, THE SURGEON NOTED THAT THE SCREWS AND PLATE WERE BACKING OUT. THE PATIENT WAS EXPERIENCING SOME PAIN AND UNDERWENT REVISION SURGERY ON (B)(6) 2019 TO REPLACE THE PLATE AND SCREWS.
Patient problems: Injury; Pain
MAUDE report 8522829 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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