CD HORIZON® SOLERA® Spinal System 54850016535Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS 54850016535 4.75 EXT TAB CANN 6.5X35 · Class 2 · Implant
All models of CD HORIZON SOLERA Spinal System (34)
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 00643169491311), received between Jun 17, 2025 and Jun 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DECOMPRESSION AND FIXATION L4-L5-S1. IT WAS REPORTED THAT THE SCREW WAS BROKEN. AFTER THE INITIAL SURGERY ON (B)(6) 2024, INVOLVING DECOMPRESSION AND FIXATION AT L4-L5-S1 WITH VOYAGER 4.75, THE PATIENT EXPERIENCED RADICULAR PAIN ON THE LEFT SIDE. AN IMAGING STUDY REVEALED A FRACTURE OF THE PEDICLE SCREW AT S1 ON THE LEFT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, TO REPLACE THE LEFT S1 SCREW WITH A 7.5X40MM SCREW. DURING THIS REVISION SURGERY, AN INTERBODY FUSION AT L4-L5 AND L5-S1 WAS CONDUCTED VIA AN ANTERIOR RETROPERITONEAL APPROACH TO ACHIEVE CIRCUMFERENTIAL ARTHRODESIS OF THE AFFECTED LEVELS. IT WAS NOTED THAT THE SPECIFIC BROKEN SCREW COULD NOT BE IDENTIFIED AS THE EXPLANTED IMPLANT WAS DISCARDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pain
MAUDE report 22220772 ↗
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- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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