CD HORIZON® Spinal System 25630019590Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 25630019590 BS CNCMAS 9.5X90 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169412729), received between Feb 21, 2019 and Jun 22, 2021 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Break1
- Material Deformation1
Patient problems
- Bone Fracture(s)1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2021Material Deformation; Material Deformation
THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH SPINE STABILIZATION/FUSION FOR THORACOLUMBAR FUSION SPINAL THERAPY. IT WAS REPORTED THAT FROM RIGHT SIDE IMPLANTS THE SET SCREW WAS LOOSE. SADDLE OF THE BALLAST SCREW SEEMED DEFECTIVE WHEN HE USED THE TULIP ALIGNER FOR SCREW REMOVAL. FROM LEFT SIDE IMPLANTS SET SCREW SEEMED TIGHT AND NORMAL. TULIP ANGLE OF BALLAST SCREW SEEMED CHANGED SINCE POST OP STANDING FILMS. THE PATIENT HAD PELVIC FRACTURE SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. REMOVAL OF BALLAST SCREWS, SET SCREWS AND RODS. REPLACED WITH LARGER DIAMETER BALLAST SCREWS, NEW SET SCREWS AND NEW RODS. IT WAS UNSURE IF THE RODS HAD ANY PART OF THE PRODUCT FAILURE. SENT THEM WITH THE SCREWS AND THE SET SCREWS SO ALL AVAILABLE IMPLANTS WERE TOGETHER TO GET TESTED. WE CAN NOT SAY WITH CERTAINTY THE FRACTURE WAS A RESULT OF THE IMPLANTS.
Patient problems: Bone Fracture(s)
MAUDE report 12038712 ↗InjuryFeb 21, 2019Break; Break
IT WAS REPORTED THAT DURING USE, THE SCREW BROKE AT BASE OF HEAD. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT. SCREW WAS BEING REMOVED BECAUSE PATIENT HAD AN INFECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8356975 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- 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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