XIA 4.5 System - XIA CT 488526530Recalls & reported problems
Stryker Corporation · Cannulated Polyaxial Cortical Screw · Class 2 · Implant
All models of XIA 4.5 System - XIA CT (8)
Data updated Oct 18, 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 07613327134551), received between Nov 28, 2018 and Nov 28, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (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 18, 2026.
Most reported problems
Device problems
- Device Slipped1
- Migration1
Patient problems
- Injury1
- Numbness1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2018Migration; Device Slipped; Migration
PATIENT UNDERWENT AN L4 TO S1 LUMBAR FUSION ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT COMPLAINED OF PAIN AND NUMBNESS. X-RAY SHOWED THE RODS CONNECTING THE L4 TO S1 SCREWS HAD SLIPPED ON THE S1 SCREWS. REVISION SURGERY WAS PERFORMED.
Patient problems: Injury; Numbness; Pain
MAUDE report 8112637 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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