CD HORIZON® Spinal System 25530019590Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 25530019590 BS CNCMAS 9.5X90 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169414310), received between Mar 27, 2024 and Mar 27, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Foreign Body Reaction1
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAD OLIF (L2/3/4) AND T10~SAI FIXATION AND L5/SPLIF FROM THE REAR. IT WAS REPORTED THAT THE LOOSE SCREW CAUSED INFECTION IN PATIENT. ALTHOUGH FIXATION WAS PERFORMED FROM T10 TO SAI, A WOUND APPEARED ON THE SKIN OF THE RIGHT SAI AREA AND PUS ALSO CAME OUT. WHEN IT WAS DEPLOYED, THE TISSUE FROM THE SKIN SURFACE TO THE SCREW HEAD CONTINUED TO HAVE DARK GRANULATION, AND THERE WAS PUS IN THE SURROUNDING AREA. THE SET SCREW IN THE SCREW HEAD WAS LOOSE ENOUGH THAT IT COULD BE REMOVED WITH FORCEPS, AND THE SURROUNDING TISSUE SHOWED DARK SPOTS AND BLACK POWDERY MATTER. THE SCREW THAT HAD BEEN INSERTED HAD A CLEAR ZONE ON THE IMAGE, BUT IT WAS REASONABLY EFFECTIVE. THE RIGHT SIDE WAS IN A NOTICEABLE CONDITION, BUT WHEN CHECKED THE LEFT SIDE, IT WAS IN THE SAME CONDITION. A REVISION SURGERY WAS PERFORMED DUE TO SUSPICION OF METALLOSIS DUE TO WEAR PARTICLES OF THE IMPLANT, BLACK GRANULATION ON THE SOFT TISSUES, WOUNDS ON THE WOUND SURFACE AND PUS IN THE VICINITY. IMPLANT WAS CUT AND REMOVED. INITIAL SURGERY WAS DONE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED. THE SET SCREWS WERE L
Patient problems: Foreign Body Reaction; Post Operative Wound Infection
MAUDE report 18984825 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
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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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