CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750014535Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS 54750014535 4.75 EXT TAB CN 4.5X35 S · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169501164), received between Jan 6, 2025 and Jan 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2025Material Twisted/Bent; Material Twisted/Bent
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A POSTERIOR LUMBAR FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR COMPRESSION FRACTURE. IT WAS REPORTED THAT AFTER OPENING/UNPACKING THE SCREW, THE NURSE REPORTED THAT ATTACHING THE EXTENDER TAB WAS TRIED, BUT THE TAB ON THE SIDE OF THE SCREW WAS BENT AND COULD NOT BE ATTACHED. THE DEVICE WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE COMPLETED SUCCESSFULLY. THE SCREWS DID NOT COME IN CONTACT WITH THE PATIENT. BOTH REPORTED SCREWS WERE BENT. THE ISSUE WAS NOTICED WHEN THE TABS WERE BEING ATTACHED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078355 ↗
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- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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