CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016530Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS 54750016530 4.75 EXT TAB CN 6.5X30 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169501300), received between Nov 11, 2019 and Nov 11, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).
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
- Migration or Expulsion of Device2
Patient problems
- Paralysis2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH SPINAL CANAL STENOSIS; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AND POSTERIOR PEDICLE SCREW FIXATION AT L4-L5. ON AN UNKNOWN DATE, POST-OP, THE LOWER END PLATE OF L4 FRACTURED DUE TO PATIENT'S SLIGHT CARELESSNESS, AND THE IMPLANTED SCREW AT RIGHT OF L5 LOOSENED. ALLEGEDLY, THE PATIENT ALSO GOT PARALYZED DUE TO THIS EVENT. HENCE, AN EMERGENCY REVISION SURGERY WAS PERFORMED, IN WHICH THE LOOSENED SCREW WAS REPLACED AND ADDITIONAL SCREW INSERTION WAS PERFORMED ON BOTH SIDES OF L3. FIXATION WAS PERFORMED AGAIN.
Patient problems: Paralysis
MAUDE report 9305213 ↗InjuryNov 11, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH SPINAL CANAL STENOSIS; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AND POSTERIOR PEDICLE SCREW FIXATION AT L4-L5. ON AN UNKNOWN DATE, POST-OP, THE LOWER END PLATE OF L4 FRACTURED DUE TO PATIENT'S SLIGHT CARELESSNESS, AND THE IMPLANTED SCREW AT RIGHT OF L4 LOOSENED. ALLEGEDLY, THE PATIENT ALSO GOT PARALYZED DUE TO THIS EVENT. HENCE, AN EMERGENCY REVISION SURGERY WAS PERFORMED, IN WHICH THE LOOSENED SCREW WAS REPLACED AND ADDITIONAL SCREW INSERTION WAS PERFORMED ON BOTH SIDES OF L3. FIXATION WAS PERFORMED AGAIN.
Patient problems: Paralysis
MAUDE report 9305120 ↗
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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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