CD HORIZON® Spinal System 25840018570Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 25840018570 BS CNMAS 8.5X70 T/C · 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 00643169413252), received between Sep 14, 2020 and Feb 26, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Migration1
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SCOLIOSIS AT T2-PELVIS. IT WAS REPORTED THAT THE SET CAP DISASSEMBLED FROM THE ROD AND SCREW HEAD. THE PATIENT EXPERIENCED POST-OPERATIVE PAIN. SOLID FUSION WAS ACHIEVED, AS CONFIRMED BY X-RAY IMAGING. NO ADDITIONAL SURGERY OR TREATMENT WAS PERFORMED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO REVISION SURGERY PLANNED.
Patient problems: Pain
MAUDE report 24452400 ↗InjurySep 14, 2020Migration; Migration
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT SCREW POPPED OFF FROM BALLAST SCREW TULIP HEAD. THERE WAS PATIENT INVOLVED IN THE EVENT AND REPORTED AS PAIN DUE TO ROD DISPLACEMENT FROM SCREW. REVISION SURGERY TO CORRECT ROD DISPLACEMENT FROM SCREW WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-AUG-27 THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017 AND REVISION SURGERY WAS SCHEDULE ON (B)(6) 2020 TO REPLACE THE SET SCREW ON BALLAST SCREW. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-AUG-28: THE PRE-OP DIAGNOSIS OF THE EVENT WAS REVISION SURGERY FOR BALLAST SCREW FAILURE.
Patient problems: Pain
MAUDE report 10527115 ↗
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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