CD HORIZON® SOLERA® Spinal System 54850017555Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS 54850017555 4.75 EXT TAB CANN 7.5X55 · 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 00643169491625), received between Dec 9, 2024 and Dec 9, 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
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.
MalfunctionDec 9, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REMOVAL OF HARD WARE AT L4, L5-S1 AND TLIF AT THE ADJACENT LEVELS L2-3 AND L3-4 FOR THE INDICATION OF LOW BACK PAIN WITH RIDICULAR PAIN AND FORAMINAL STENOSIS. IT WAS REPORTED THAT WHILE RE-INSTRUMENTING RIGHT L4 AFTER REMOVAL OF HARDWARE, THE TIP OF THE SCREWDRIVER BROKE. IT WAS ABLE TO GET THE SCREW OUT AND WHILE ADVANCING WITH A NEW SCREW , ENCOUNTERED VERY HARD BONE FROM THE PRIOR FUSION AND WHILE DRIVING THE SCREW DOWN, THE SCREW HEAD BROKE. SO, THE PHYSICIAN PLACES THE SCREW BACK INTO RIGHT S1 TO BE ABLE TO SPAN THE ROD ACROSS NEW F USION LEVELS. THE BROKEN SCREW POST WAS IMPLANTED AS IT IS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20876721 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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