REFLEX HYBRID 48511906Recalls & reported problems
Stryker Corporation · REVISION DRIVER · Class 1
All models of REFLEX HYBRID (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327271003), received between May 24, 2016 and Oct 3, 2016 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break4
- Fracture2
- Material Deformation2
- Material Integrity Problem2
Patient problems
- No Known Impact Or Consequence To Patient4
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; DURING ANTERIOR CERVICAL ARTHRODESIS PROCEDURE (3 LEVELS), THE SURGEON USED THE SCREWDRIVER TO INSERT THE SCREW AND IT BROKE. THE SURGEON USED ANOTHER SCREWDRIVER TO FINISH THE PROCEDURE.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 5994930 ↗MalfunctionOct 3, 2016Fracture; Break; Fracture
IT WAS REPORTED THAT; DURING ANTERIOR CERVICAL ARTHRODESIS PROCEDURE (3 LEVELS), THE SURGEON USED THE SCREWDRIVER TO INSERT THE SCREW AND IT BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5994902 ↗MalfunctionJun 1, 2016Break; Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TOP OF THE SCREW EXTRACTOR WAS BROKEN DURING SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5692855 ↗MalfunctionMay 24, 2016Break; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT; AFTER SURGEON HAS INSERTED THE SCREW, AND REMOVING THE INSTRUMENT, SURGEON NOTICED THAT THE TIP OF INSTRUMENT WAS DAMAGED AND COULD NOT BE USED ON ANOTHER SURGERY. THE PROCEDURE WAS AN CERVICAL ANTERIOR ARTHRODESIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5677123 ↗
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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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