XIA 3 48238090Recalls & reported problems
Stryker Corporation · TI ALLOY RAD 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540560971), received between Mar 16, 2017 and Mar 16, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Mechanical Problem1
- Migration or Expulsion of Device1
Patient problems
- Injury1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2017Mechanical Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Migration or Expulsion of Device
IT WAS REPORTED THAT; PATIENT RECEIVED A REVISION SURGERY ON (B)(6) 2017, THE SURGEON REMOVED THE SET SCREWS AND RODS, VERIFIED THAT ALL PEDICLE SCREWS SEEMED SOLID, AND PLACED NEW, LARGER RODS AND NEW SET SCREWS. THE NEW SET SCREWS WERE THEN TIGHTENED TO 12 NM WITH THE TORQUE LIMITING FINAL TIGHTENER. FOLLOWING THE HARDWARE REVISION SURGERY THE PATIENT DEVELOPED SIGNS OF INFECTION AND ON (B)(6) 2017. A SUBSEQUENT SURGERY WAS PERFORMED FOR WOUND WASH-OUT AND DEBRIDEMENT.
Patient problems: Injury; Unspecified Infection
MAUDE report 6410572 ↗
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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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