CD HORIZON® Spinal System X0812103Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCR X0812103 SOL 5.5/6.0 RED UAS 6.0X35 · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169355569), received between Jul 10, 2024 and Jul 10, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SPONDYLITIS. IT WAS REPORTED THAT THE SCREWS WERE BROKEN AFTER 4 MONTHS OF OPERATION. PAIN WAS REPORTED DUE TO BROKEN SCREWS AND NO FUSION HAPPENED. ORIGINAL SURGERY WAS AT L4-S1. REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN SCREWS. REVISION WAS AN EXTENSION TO PELVIS WITH REMOVAL OF BROKEN SCREWS. PRODUCTS WILL BE RETURNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS L4-S1 POSTERIOR LUMBAR FUSION.
Patient problems: Pain
MAUDE report 19707971 ↗InjuryJul 10, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SPONDYLITIS. IT WAS REPORTED THAT THE SCREWS WERE BROKEN AFTER 4 MONTHS OF OPERATION. PAIN WAS REPORTED DUE TO BROKEN SCREWS AND NO FUSION HAPPENED. ORIGINAL SURGERY WAS AT L4-S1. REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN SCREWS. REVISION WAS AN EXTENSION TO PELVIS WITH REMOVAL OF BROKEN SCREWS. PRODUCTS WILL BE RETURNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS L4-S1 POSTERIOR LUMBAR FUSION.
Patient problems: Pain
MAUDE report 19707954 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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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