XIA 3 482317570Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
All models of XIA 3 (93)
Data updated Oct 18, 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 04546540562395), received between Nov 22, 2016 and Nov 22, 2016 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Difficult to Remove1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2016Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem; Difficult to Remove
IT WAS REPORTED THAT THE LEFT SCREW FROM LILAC BONE WAS BEING ATTEMPTED TO BE REMOVED. HOLDING THE SCREW HEAD DURING LOCKED THE OUTER TUBE OF SCREW DRIVER, ATTEMPTED TO LOSE THE SCREW, HOWEVER REMOVED SCREW HEAD ONLY. REMOVED THE REMAINING SCREW PART IN LILAC BONE USING ADJUSTMENT DRIVER AND COMPLETE TO REMOVE SCREW WHOLE. ADDITIONAL INFORMATION RECEIVED FROM SR BY PHONE ON 4-NOV-2016. IMPLANTED XIA3(ILIA) AND ES2(LUMBAR) BOTH FOR FRACTURES ON (B)(6) 2015. AND REMOVED XIA3 AS PLANNED ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6122748 ↗
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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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