CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017555Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55750017555 5.5VOYAGER STMAS7.5X55 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169783935), received between Jun 30, 2023 and Jun 30, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
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.
MalfunctionJun 30, 2023Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4 SET SCREW RE PLACEMENT FOR AN INDICATION OF INADEQUATE BONE FUSION AFTER POSTERIOR FUSION. IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY OF POSTERIOR FIXATION BY L3/4DEPS TECHNIQUE AND POSTERIOR FIXATION BY S1/S2AI A ND REVISION SURGERY WAS PERFORMED DUE TO BONE FUSION FAILURE AFTER POSTERIOR FIXATION. THERE WAS NO MALFUNCTION WITH MDT PRODUCTS THAT RESULTED IN BONE FUSION FAILURE. DURING REVISION SURGERY, WHILE THE SET SCREW WAS ABOUT TO BE INSTALLED, IT WAS HARD LIKE A CROSS-THREAD, AND THE SET SCREW WAS REPLACED WITH A NEW ONE, BUT NO IMPROVEMENT. IT APPEARED THAT THE SCREW HEAD THREAD ITSELF MAY HAVE BEEN DEFORMED, AND WHEN THE SCREW WAS REPLACED AND THE SET SCREW WAS REPLACED AGAIN WITH ANOTHER ONE, THE PROBLEM WAS RESOLVED. WHILE THE SET SCREW IS A TITANIUM ALLOY, IT IS UNLIKELY THAT THE THREAD OF THE COBALT-CHROME ALLOY SCREW HEAD WAS PUSHED DOWN AND CRUSHED, BUT IT IS UNCLEAR WHETHER THE PROBLEM WAS ON THE SET SCREW OR THE SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17237175 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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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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