XIA 3 48232110Recalls & reported problems
Stryker Corporation · CP TI ROD · Class 2 · Implant
All models of XIA 3 (93)
Data updated Oct 16, 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 04546540560520), received between Jun 24, 2019 and Jun 24, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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 16, 2026.
Most reported problems
Device problems
- Biocompatibility1
- Patient-Device Incompatibility1
Patient problems
- Itching Sensation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2019Biocompatibility; Patient-Device Incompatibility; Biocompatibility
PHYSICIAN REPORTED ¿A PATIENT IMPLANTED IN (B)(6) 2017 WITH ¿SCREWS AND ROD¿ HAS DEVELOPED A GENERALIZED PRURITUS THAT DOES NOT DISAPPEAR SINCE THE IMPLANTATION.¿ THE PHYSICIAN SUGGESTS THE PATIENT MAY HAVE AN ALLERGY TO A COMPONENT OF THE DEVICE. DETAILS OF SPECIFIC MEDICAL INTERVENTION HAVE NOT BEEN PROVIDED AND THE PATIENT HAS CONSULTED WITH A DERMATOLOGIST. THIS RECORD REPRESENTS 2 OF 2 RODS.
Patient problems: Itching Sensation
MAUDE report 8729384 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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