XIA 4 5 48133200Recalls & reported problems
Stryker Corporation · TITANIUM ROD · Class 2 · Implant
All models of XIA 4 5 (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540449405), received between Dec 19, 2018 and Dec 19, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Fracture2
Patient problems
- Injury2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2018Fracture; Break; Fracture
IT WAS REPORTED ROD WAS BROKEN POST-OPERATIVELY. AS PER THE EMAIL COMMUNICATION WITH REP, THE REVISION SURGERY WAS PLANNED ON (B)(6) 2018.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 8178558 ↗InjuryDec 19, 2018Fracture; Break; Fracture
IT WAS REPORTED ROD WAS BROKEN POST-OPERATIVELY. AS PER THE EMAIL COMMUNICATION WITH REP, THE REVISION SURGERY WAS PLANNED ON (B)(6) 2018.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 8178557 ↗
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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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