RADIUS 486614110Recalls & reported problems
Stryker Corporation · CROSS CONNECTOR, VARIABLE MEDIUM · Class 2 · Implant
All models of RADIUS (13)
Data updated Oct 18, 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 04546540546173), received between Jan 9, 2017 and May 15, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 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
- Material Integrity Problem2
- Break1
- Connection Problem1
- Difficult to Insert1
- Material Deformation1
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.
MalfunctionMay 15, 2017Connection Problem; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT; WHEN THE SET SCREWS ON BOTH SIDES OF THE CROSS CONNECTOR VARIABLE WERE FIXED FINALLY, THE INTEGRATED SET SCREW WAS DISENGAGED. ANOTHER CROSS CONNECTOR WAS USED AND COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6567278 ↗MalfunctionJan 9, 2017Break; Difficult to Insert; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT; DURING SURGERY (L5/S TLIF), THE SCREW OF THE CONNECTOR BROKE WHEN THE SURGEON STRIKED THE SCREW BECAUSE IT WAS DIFFICULT TO FIT THE CONNECTOR TO THE ROD. THE SURGEON USED OTHER CONNECTOR AND FINISHED THE SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6234299 ↗
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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