CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016535Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS 54750016535 4.75 EXT TAB CN 6.5X35 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
- 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 00643169501089), received between Nov 23, 2016 and Jan 23, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
- Product Quality Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2025Product Quality Problem; Tear, Rip or Hole in Device Packaging; Product Quality Problem; Tear, Rip or Hole in Device Packaging
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR VERTEBROPLASTY AND POSTERIOR FUSION. IT WAS REPORTED THAT WHEN THE CIRCULATING NURSE OPENED THE IMPLANT, THE SCREW BROKE THROUGH THE PLASTIC CASE AND THE TIP WAS PROTRUDING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21215492 ↗InjuryNov 23, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
PRE-OP DIAGNOSIS (REVISION SURGERY): RIGHT S1 SCREW DEVIATED PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS INVOLVED: L4/5 IT WAS REPORTED THAT ON ON AN UNKNOWN DATE, POST-OP, THE SCREW AT THE RIGHT OF S1 DEVIATED. HENCE, A REVISION SURGERY WAS PERFORMED IN WHICH THE SCREW(DIAMETER- 6.5 MM) WAS REPLACED WITH SCREW OF DIAMETER 7.5 MM.
Patient problems: No Code Available
MAUDE report 6123606 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
- CD HORIZON® Spinal System 5540030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis230 reports
- CD HORIZON® Spinal System 7578302Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis122 reports
- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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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