REFLEX HYBRID 48651237Recalls & reported problems
Stryker Corporation · TWO-LEVEL PLATE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540534835), received between Feb 26, 2016 and Jan 27, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Device Dislodged or Dislocated1
- Difficult to Remove1
- Inadequacy of Device Shape and/or Size1
- Mechanical Jam1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2017Difficult to Remove; Inadequacy of Device Shape and/or Size; Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT; DURING MEDICAL PROCEDURE SURGEON USED A TWO LEVEL PLATE, AFTER LOCATION USED A XRAY TWO VERIFY POSITION OF SCREWS AND DECIDE TO REMOVE THEM DUE TO THEY ARE TOO SHORT USING THE SAME SCREWDRIVER USED TO INTRODUCE THEM. THE FIRST SCREW FROM INFERIOR SIDE WAS UNABLE TO EXTRACT AS WELL AS ONE SCREW IN SUPERIOR SIDE, THE OTHER 2 SCREWS WERE REMOVED WITHOUT ISSUES. THE SURGEON DECIDE TO USE TWO NEW LARGER SCREWS IN ORDER TO FIX THE PLATE TO THE BONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6282714 ↗MalfunctionFeb 26, 2016Mechanical Problem; Device Dislodged or Dislocated; Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT; DURING A 2L ACF, AS DR WAS REMOVING THE DRILL GUIDE FROM THE HYBRID PLATE, HE NOTICED IT DAMAGED THE RING. HAD TO CHANGE PLATE. SO AS HE IS REMOVING THE SCREWS, PART OF THE THREAD OF ONE OF THE VAST SCREWS CAME OFF. HE RETRIEVED ALL OF IT. USED THE SAME SIZE PLATE AND FINISHED THE PROCEDURE. DELAY OF 4-5 MINUTES
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5464020 ↗
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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 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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