CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850047545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55850047545 5.5/6.0 SV ATS 7.5X45 · 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 00643169745353), received between Dec 15, 2022 and Dec 15, 2022 — classified as 1 malfunction.
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
- Numbness1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM CONSUMER AND HEALTH CARE PROFESSIONAL (HCP) VIA MANUFACTURING REPRESENTATIVE REGARDING AN EVENT IDENTIFIED POST OP A L4-S1 TLIF IN A PATIENT DIAGNOSED WITH LUMBAR DISCECTOMY. IT WAS REPORTED THAT PEDICEL SCREW WAS LOOSENING. AFTER SURGERY PATIENT NOTICED THAT DURING MORNINGS NUMBNESS IS RETURNING AND ALSO THE FEELING OF A WISHBONE BEING PULLED APART. PAIN IS CONSISTENT BUT FLUCTUATING. BASED ON THE RADIOGRAPHIC STUDIES BY HCP, POSTSURGICAL CHANGES ARE AGAIN NOTED STATUS POST L4-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION, L4-L5 AND L5-S1 DISCECTOMY WITH INTERBODY CAGES AT L4-L5 AND L5-S1. ADDITIONAL POSTSURGICAL CHANGES ARE NOTED FROM RIGHT-SIDED HEMILAMINECTOMY AT L4-L5. HARDWARE IS INTACT WITHOUT EVIDENCE OF PERIPROSTHETIC FRACTURE. HOWEVER, THERE IS REDEMONSTRATIONS OF LUCENCY/OSTEOLYSIS SURROUNDING THE L4 PEDICLE SCREWS BILATERALLY, RIGHT GREATER THAN LEFT WITH FINDINGS MILDLY PROGRESSED WHEN COMPARED TO 10/27/2022. FINDINGS ARE CONCERNING FOR HARDWARE FAILURE/LOOSENING. THE REMAINING HARDWARE DEMONSTRATES NO EVIDENCE OF PERIPROSTHETIC FRACTURE OR OSTEOLYSIS. VERTEBRAL BODY HEIGHTS ARE PRESERVED. INTERVERTEBRAL DISC SPACE HEIGHTS ARE PRESERVED. AN S1
Patient problems: Numbness; Pain
MAUDE report 15985627 ↗
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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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