XIA 3 482378560Recalls & reported problems
Stryker Corporation · CLOSED HEAD POLYAXIAL SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327000962), received between Mar 8, 2016 and Mar 8, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2016Break; Detachment of Device or Device Component
IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT THE SURGERY . ON (B)(6) 2016, THE SURGEON CONFIRMED X-RAY AND FOUND THAT THE SCREW HEAD WAS BROKEN OFF. THEREFORE, THE SURGEON IS PLANNING A REVISION SURGERY ON (B)(6) 2016. IT'S BEING FIXED IN (B)(6) 2015 FROM A UPPER THORACIC VERTEBRA TO THE MID LUMBER VERTEBRA, BUT THE IMPLANTS ISN'T CONNECTED WITH FIXING IN 2013.
Patient problems: No Code Available
MAUDE report 5486488 ↗
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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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