CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750015540Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS 54750015540 4.75 EXT TAB CN 5.5X40 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169501249), received between Jul 13, 2018 and Nov 7, 2024 — classified as 2 injuries, 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
- Loose or Intermittent Connection1
- Migration or Expulsion of Device1
- Use of Device Problem1
Patient problems
- Unspecified Infection2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2024Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A POSTERIOR DECOMPRESSION FIXATION PROCEDURE. IT WAS REPORTED THAT THE SCREW WAS INSERTED WITH A DIFFERENT TRACK IN CONSIDERATION OF THE RISK OF BACKOUT DUE TO SCREW LOOSENING. THE LENGTH WAS CHANGED. 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 20632382 ↗InjuryOct 30, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
POST OP, THE PATIENT HAD TO UNDERWENT REVISION SURGERY BECAUSE THE PEDICLE SCREW ON THE RIGHT OF L1 WHICH WAS ON THE MOST CRANIAL SIDE BACKED OUT DUE TO LOOSENING. DURING REVISION THE SURGEON CUT THE ROD BETWEEN L1/2 AND REMOVED ONLY THE PEDICLE SCREW ON THE RIGHT OF L1. THE BACKED OUT PEDICLE SCREW PROTRUDES TO THE SKIN, AND IT WAS SUSPECTED THAT INFECTION OCCURRED THERE. THE NEARBY SOFT TISSUE WAS COLLECTED AND CULTURED.
Patient problems: Unspecified Infection
MAUDE report 9254391 ↗InjuryJul 13, 2018Loose or Intermittent Connection
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: Unspecified Infection
MAUDE report 7685826 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
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- 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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