CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017550Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55750017550 5.5VOYAGER STMAS7.5X50 · 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 00643169783928), received between Sep 19, 2022 and Sep 19, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN A 2-2 FIXED PPS FOR L4 RUPTURE FRACTURE (SUSPECTED META) AND EXPLANTED IN A TOP EXTENSION FOR A COMPRESSION FRACTURE AT L2-S. IT WAS REPORTED THAT THE SCREWS BACKED OUT. IT WAS LOOSENED AND LOCKED IN THE LEFT HAND SIDE OF L2 BUT IN THE RIGHT SIDE OF L2 AND BOTH SIDES OF L3 HAVE LOOSENED, SO THE 4 OF IT WERE SIZED UP AND REPLACED. SCREW WAS ADDED TO TH12/L1, ALL OF WHICH WERE CONCURRENTLY USED WITH HA STICK. THE ROD WAS FASTENED IN THE TH12-S. BONE TRANSPLANT WAS PERFORMED USING LOCAL BONE +GR. THERE WAS NO IMPACT ON PATIENT. THE DATE OF IMPLANT WAS (B)(6) 2022 AND DATE OF EXPLANT WAS (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15444771 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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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