CD HORIZON® Spinal System 25000300Recalls & reported problems
Medtronic Sofamor Danek, Inc. · PROBE 25000300 CURVED · Class 1
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 00643169623989), received between May 16, 2021 and May 16, 2021 — 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.
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.
MalfunctionMay 16, 2021Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING UNKNOWN SPINAL PROCEDURE WITH PRE-OPERATIVE DIAGNOSIS OF NEURAL FORAMINAL STENOSIS OF LUMBAR SPINE, LUMBAR STENOSIS WITHOUT NEUROGENIC CLAUDICATION, SYNOVIAL CYST OF LUMBAR FAUCET JOINT, LUMBAR SPONDYLOSIS WITH MYELOPATHY. IT WAS REPORTED THAT, THE TIP OF THE BALLAST PROBE BROKE OFF IN THE PATIENT¿S ILIUM AND THE BROKEN TIP WAS LEFT IN THE BONE. PATIENT IS NON SMOKING, NON ALLERGIC AND HAD A PREVIOUS ACDF. THERE WAS A DELAY OF 3 MINUTES REPORTED. THERE WAS NO REVISION SURGERY SCHEDULED TO RETRIEVE THE BROKEN TIP LEFT IN THE BONE. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11830150 ↗
Other PROBE devices
- EXPEDIUM 279702030Depuy Spine, LLC · PROBE53 reports
- Sklar 96-2361Sklar Corporation · PROBE1 recall0 reports
- Sklar Instruments 94-5923Sklar Corporation · PROBE1 recall0 reports
- MOSS 275010140Depuy Spine, LLC · PROBE28 reports
- EXPEDIUM 279702040Depuy Spine, LLC · PROBE21 reports
- MULTILOC 03.019.029Synthes GmbH · PROBE15 reports
- MOSS 275010160Depuy Spine, LLC · PROBE11 reports
- EXPEDIUM 279702010Depuy Spine, LLC · PROBE9 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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