CD HORIZON® Fenestrated Screw Set 55750025535Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS MAS 55750025535 STER CCM 5.5 X 35 · Class 2 · Implant
All models of CD HORIZON Fenestrated Screw Set (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000149567), received between Jan 2, 2025 and Jan 2, 2025 — classified as 2 malfunctions.
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
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FIX FOR TRAUMA FRACTURE. IT WAS REPORTED THAT A SCREW FRACTURED, AND A FRAGMENT WAS LEFT IN THE PATIENT. IT WAS NOTED THAT ONE OF THE SCREWS BROKE DURING THE REMOVAL OF IMPLANTS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DIFFICULTY NOTICED WHEN EXTRACTING SCREWS FOR ROUTINE REMOVAL OF METAL. TWO LOT NUMBERS WERE REPORTED AND IT IS UNSURE WHICH LOT WAS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21054169 ↗MalfunctionJan 2, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FIX FOR TRAUMA FRACTURE. IT WAS REPORTED THAT A SCREW FRACTURED, AND A FRAGMENT WAS LEFT IN THE PATIENT. IT WAS NOTED THAT ONE OF THE SCREWS BROKE DURING THE REMOVAL OF IMPLANTS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DIFFICULTY NOTICED WHEN EXTRACTING SCREWS FOR ROUTINE REMOVAL OF METAL. TWO LOT NUMBERS WERE REPORTED AND IT IS UNSURE WHICH LOT WAS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21052922 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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