XIA II 03829640Recalls & reported problems
Stryker Corporation · POLYAXIAL REDUCTION SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154407880), received between Jun 5, 2020 and Jun 5, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Jam” (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
- Mechanical Jam1
- Migration1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2020Mechanical Jam; Migration; Mechanical Jam; Migration
IT WAS REPORTED THAT AFTER IMPLANTING A XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 40MM AT S1, THE SURGEON ATTEMPTED TO REMOVE A AND REPLACE WITH A LARGER DIAMETER SCREW INTRA-OPERATIVELY. THERE WAS DIFFICULTY REMOVING THE SCREW RESULTING IN A SURGICAL DELAY OF MORE THAN ONE HOUR. ONCE REMOVED, IT WAS DISCOVERED THAT THE END OF THE SCREW WAS SEPARATED FROM THE SHAFT ROD. NO ADVERSE CONSEQUENCES OR HARM TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10125068 ↗
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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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