CD HORIZON® SOLERA® Spinal System 651003035Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ROD 651003035 5.5 CCM CAPPED ROD 35MM · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169747975), received between Jun 2, 2024 and Jun 2, 2024 — classified as 1 malfunction.
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
- Malposition of Device1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2024Break; Malposition of Device; Mechanical Jam; Break; Malposition of Device; Mechanical Jam
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CAPPED ROD HAVING L4/5 POSTERIOR LUMBAR INTERBODY FUSION THERAPY FOR SPINAL INSTABILITY. IT WAS REPORTED THAT THE CAPPED END OF THE ROD BECAME LODGED IN THE TULIP OF THE SCREW HEAD WHILE INSERTING THE SET SCREW. SET SCREW WAS GROUND DOWN ONTO THE CAPPED END AND GROUND OFF SEVERAL METAL SHARDS. ROD BECAME STUCK INTO THE TULIP AND HAD TO BE PULLED OUT FIRMLY WITH A ROD HOLDER. SURGEON REFLECTED THAT THEY SHOULD HAVE CONFIRMED THEIR ROD PLACEMENT BEFORE PUTTING IN SET SCREWS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE CAPPED END OF THE ROD WAS GROUND DOWN AND METAL SHARDS WERE CREATED WHILE WITHIN THE PATIENT. METAL SHARDS WERE ALL REMOVED IMMEDIATELY AS IT HAPPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19444621 ↗
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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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