CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850018545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55850018545 5.5 VOYAGER MAS 8.5X45 · Class 2 · Implant
All models of CD HORIZON SOLERA VOYAGER Spinal System (60)
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 00643169768499), received between Mar 17, 2021 and Mar 17, 2021 — 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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2021Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF BROKEN RIGHT S1 SCREW. IT WAS REPORTED THAT POST-OP, THE RIGHT S1 SCREW BROKE AND HAD METALOSIS AROUND THE SCREW HEAD. LEFT S1 AND BILATERAL L5 WERE INTACT. PATIENT HAD PAIN. REVISION SURGERY IS DONE AND SCREWS WERE REPLACED. THERE WERE NO FRAGMENTS LEFT IN PATIENT.
Patient problems: Pain
MAUDE report 11501980 ↗
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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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