CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750017550Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS 54750017550 4.75 EXT TAB CN 7.5X50 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169501119), received between Jul 4, 2018 and Jul 4, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 4, 2018Break; Break
INITIAL SURGERY: TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) WAS PERFORMED ON L4/5/S REASON FOR REVISION SURGERY: DEGENERATIVE SCOLIOSIS REVISION SURGERY: OLIF (OBLIQUE LUMBAR INTERBODY FUSION) WAS PERFORMED ON TH10-S L1-4 IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT A TLIF SURGERY IN WHICH A SCREW WAS IMPLANTED. POST-OP, PATIENT SUFFERED WITH DEGENERATIVE SCOLIOSIS DUE TO WHICH PATIENT HAD TO UNDERGO A REVISION OLIF SURGERY. DURING THE REVISION SURGERY, THE SCREW BROKE WHEN A SEQUENTIAL REDUCER WAS ATTACHED TO ITS HEAD. THE SCREW HEAD WAS EXTRACTED BUT THE TIP REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Discomfort
MAUDE report 7662231 ↗
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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