CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750047535Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55750047535 ST 5/6 SV ATS 7.5X35 · 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
- 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 00643169749085), received between Nov 14, 2022 and Nov 14, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
- Use of Device Problem1
Patient problems
- Unspecified Nervous System Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2022Use of Device Problem; Migration; Use of Device Problem; Migration
IT WAS REPORTED THAT AFTER THE PROCEDURE THE SCREWS WERE DEVIATED. THERE IS A POSSIBILITY OF L5 ROOT SYMPTOMS AFTER SURGERY AND PROLONGED HOSPITALIZATION TO FIX AGAIN THROUGH REVISION SURGERY. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED SCREWS WERE DEVIATED AFTER INITIAL SURGERY AND WERE EXPLANTED IN THE REVISION SURGERY. THE LOT NUMBERS OF THE REPORTED PRODUCTS ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT AS A RESULT OF THE VERIFICATION, IT BECAME CLEAR THAT IT WAS A HUMAN ERROR. IN A LATERAL DECUBITUS POSITION, A CAGE WAS INSERTED USING THE OLIF AT THIS HOSPITAL, AND THEN THE PERCUTANEOUS PEDICLE SCREW (PPS) WAS PERFORMED AS IS IN A LATERAL DECUBITUS POSITION. UPON NAVIGATION AFTER THE CAGE INSERTION, THE VERTEBRAL BODY MOVES DUE TO THE CAGE, SO THE O-ARM IMAGING WAS PERFORMED AGAIN NAVIGATION WAS USED; ACCIDENTALLY SELECTED THE O-ARM IMAGING DATA BEFORE INSERTING THE CAGE ON THE NAVIGATION EVEN DURING PPS, AND THE SCREW WAS INSERTED UNNOTICED AS IS. THEREFORE, IT WAS DECIDED THAT EVEN THOUGH THE SCREW INSERTION WAS ACCURATE ON THE N
Patient problems: Unspecified Nervous System Problem
MAUDE report 15786854 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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