TRIO TRAUMA 47110545Recalls & reported problems
Stryker Corporation · CANNULATED SCREW · Class 2 · Implant
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 04546540680570), received between Jun 13, 2016 and Jun 13, 2016 — classified as 1 injury.
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
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2016Break; Fracture; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE PRIMARY SURGERY FOR L1 BURST FRACTURE WAS PERFORMED ON (B)(6) 2015. AFTER THAT THE SCREW FRACTURE ON L2 LEFT WAS FOUND AND THE EXTRACTION SURGERY OF ALL IMPLANT WAS PERFORMED. THE TIP OF THE FRACTURED SCREW WAS LEFT IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; Injury
MAUDE report 5721584 ↗
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- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 reports
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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