CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750015535Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55750015535 5.5VOYAGER STMAS5.5X35 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169783751), received between Sep 13, 2024 and May 21, 2025 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Use of Device Problem; Use of Device Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L2 OLIF ON UPPER AND LOWER L2, POSTERIOR FIXATION IN A PATIENT DIAGNOSED WITH L2 VERTEBRAL FRACTURE. IT WAS REPORTED THAT WHEN A SCREW (WITHOUT A LATERAL HOLE) WAS SCHEDULED TO BE INSERTED INTO L2 OF THE AFFECTED VERTEBRA, A SCREW (WITH A LATERAL HOLE) WAS INSERTED BY MISTAKE, RESULTING IN THE CORRESPONDING IMPLANT BEING LEFT OVER. INCORRECT SCREW WAS PROVIDED BY SALES REP. 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 22059235 ↗MalfunctionSep 13, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN S PINAL PROCEDURE FOR T5/6 PYOGENIC SPONDYLITIS. IT WAS REPORTED THAT THE TAB COULD NOT BE REMOVED AND AN ATTEMPT WAS MADE TO REMOVE THE SCREW BLADE FROM THE TAB, BUT IT DID NOT COME OFF AND APPEARED TO BE DEFORMED. THE BLADE THAT COULD NOT BE REMOVED FROM THE TABS WERE LEFT IN PLACE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20210725 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- 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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