CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750015545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS 54750015545 4.75 EXT TAB CN 5.5X45 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169501256), received between Jul 13, 2018 and Nov 26, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Fracture1
- Loose or Intermittent Connection1
- Material Twisted/Bent1
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Post Operative Wound Infection1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2024Material Twisted/Bent; Mechanics Altered; Material Twisted/Bent; Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED ON PATIENT HAVING P OSTERIOR LUMBAR FUSION THERAPY FOR LUMBAR RUPTURE FRACTURE. IT WAS REPORTED THAT WHEN THE ROD WAS BEING CONNECTED, THE SET SCREW OF THE PRODUCT COULD NOT BE INSTALLED. CONSIDERING THE EXPANSION OF THE SCREW TABS, IT WAS REPLACED WITH A NEW PRODUCT. THE SCREW TAB MAY HAD BEEN BENT AND THE PRODUCT WAS NOT IMPLANTED, HOWEVER, IT HAD CONTACT WITH THE PATIENT. THE OPERATION WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20788776 ↗InjuryJul 13, 2018Fracture; Loose or Intermittent Connection; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS POSTERIOR SPINAL FUSION AT T8-L2 DUE TO T11 FRACTURE DISLOCATION (3A3B). POST-OPERATIVE WOUND INFECTION OCCURRED AND AS A RESULT THE SCREW ON THE RIGHT SIDE BECAME LOOSE. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE SCREW.
Patient problems: Post Operative Wound Infection; Unspecified Infection
MAUDE report 7685820 ↗
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- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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