CD HORIZON® Spinal System 25740018560Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 25740018560 BS CNMAS 8.5X60 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169414891), received between Jan 11, 2025 and Apr 22, 2025 — classified as 1 injury, 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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Nervous System Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2025Malposition of Device; Malposition of Device
ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. SURGERY WAS PERFORMED FOR LCS WITHOUT L5 RADICULAR SYMPTOMS. SCREW WAS INSERTED USING MAZOR AND THE SCREW DEVIATED INTO THE SPINAL CANAL AND RADICULAR SYMPTOMS OCCURRED. RE-OPERATION OCCURRED AND IT WAS RE-INSERTED BY FREEHAND. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Unspecified Nervous System Problem
MAUDE report 21880682 ↗MalfunctionJan 11, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN SACRAL FRACTURE. IT WAS REPORTED THAT WHEN THE SET SCREW WAS TIGHTENED TO THE BALLAST SCREW, THE SET SCREW ENTERED AT AN ANGLE, AND THE FINAL TIGHTENING COULD NOT BE DONE. IT WAS POINTED OUT THAT THE SCREW HEAD WAS BROKEN. THE OPERATION WAS SUCCESSFULLY COMPLETED BY REPLACING IT WITH ANOTHER SCREW. LEVEL AT WHICH IMPLANT WAS PERFORMED L5/ILIAC. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. HENCE, NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PRODUCT CAME IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS NO MALFUNCTION WITH THE SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21133002 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
- CD HORIZON® Spinal System 5540030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis230 reports
- CD HORIZON® Spinal System 7578302Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis122 reports
- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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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