XIA 4 5 48133245Recalls & reported problems
Stryker Corporation · 45-60 mm POLYAXIAL CROSS CONNECTOR · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540515100), received between Aug 10, 2016 and Jul 3, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2020Fracture; Fracture
DURING AN OPERATION TO EXTEND THE ORIGINAL CONSTRUCT, IT WAS NOTICED THAT A XIA TITANIUM 4.5 ROD ON THE RIGHT SIDE WAS BROKEN, AS WELL AS TWO XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTORS AT THE T11-L1 AND T3/4 LEVELS. THIS REPORT REPRESENTS THE SECOND OF TWO CROSS CONNECTORS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10228264 ↗MalfunctionAug 10, 2016Break
IT WAS REPORTED THAT; DURING SMALL SURGERY, THE SURGEON USED THE CROSS CONNECTOR. AND THE SURGEON USED THE SET SCREW DRIVER. HOWEVER, IT WASN'T POSSIBLE TO TIGHTEN THE SET SCREW. WHEN THE SURGEON CHECKED THE CROSS CONNECTOR, THE SET SCREW WAS BROKEN. THEREFORE THE SURGEON CHANGED THE CROSS CONNECTOR TO ANOTHER SAME SIZE PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5865213 ↗
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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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