CD HORIZON® Spinal System 25740019580Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 25740019580 BS CNMAS 9.5X80 TC S · 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
- 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 00643169415003), received between Jan 26, 2025 and Jan 26, 2025 — 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
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT WHICH IS USED IN NAIL REMOVAL SPINAL THERAPY. IT WAS REPORTED THAT UPON CHECKING THE X-RAY AFTER THE NAIL REMOVAL, IT APPEARED THAT A WIRE-LIKE OBJECT WAS LODGED IN THE PATIENT. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT WHEN THE SCREW WAS CHECKED AFTER REMOVAL, THE WIRE PROTRUDED FROM THE HOLE IN THE HEAD OF ONE SCREW. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE DEVICE EXPLANTATION WAS DONE DUE TO BONE FUSION. THE IMPLANT DATE AND EXPLANT DATE ARE (B)(6) 2022 AND (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO ADDITIONAL SURGERY PLANNED OR SCHEDULED FOR THE REMOVAL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21236964 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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