TRIO TRAUMA 47110550Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540680587), received between Jul 14, 2016 and Jul 14, 2016 — classified as 1 malfunction.
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
- Naturally Worn1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2016Break; Naturally Worn
IT WAS REPORTED THAT; PRIMARY SURGERY WAS PERFORMED FOR L1 BURST FRACTURE ON (B)(6) 2014. TH12 AND L2 WERE FIXED WITH SCREWS, L1 WERE SKIPPED. AFTER THAT, THE FRACTURE WAS FUSED AND AN EXTRACTION SURGERY WAS PERFORMED ON (B)(6) 2016. DURING THE SURGERY, THE BREAKAGE OF L2 LEFT SCREW WAS FOUND. THE TIP OF THE BROKEN SCREW WAS REMAINED TO THE PATIENT. AND THEN, THE SET SCREW HEX OF L2 RIGHT CONNECTOR WORN WHEN THE SURGEON TRIED TO REMOVE IT. FINALLY, THE SURGEON DESTROYED THE CONNECTOR AND REMOVED IT.
Patient problems: No Code Available
MAUDE report 5796883 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
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- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- 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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