CD HORIZON® Spinal System 55811006530Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55811006530 5.5 SAS 6.5 X 30 CC · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
Data updated Oct 16, 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 00643169067554), received between Jan 16, 2023 and Jan 16, 2023 — 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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2023Break; Break
INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR SPINAL FUSION FOR PSEUDOARTHROSIS. IT WAS REPORTED THAT SOLERA SAS SCREW BROKE POSTERIORLY. REVISION SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. EXPLANT COMPLETED ON (B)(6) 2022. NO FURTHER COMPLICATIONS ANTICIPATED/REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16173613 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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