CD HORIZON® Spinal System 25000200Recalls & reported problems
Medtronic Sofamor Danek, Inc. · PROBE 25000200 NGSP PROBE · Class 1
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 00643169440289), received between Dec 10, 2020 and Nov 10, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2021Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN INDICATION FOR BILATERAL LUMBAR LAMINECTOMY L3-S1 WITH INTERBODY FUSION AND OTHER TRANSVERSE PROCESS FUSION L3-S1 WITH ILIAC WING SCREWS. IT WAS REPORTED THAT SURGEON WAS PLACING ILIAC WING SCREWS AND TIP BROKE OFF (30MM) THE PROBE INTO PATIENT. THE SURGEON IS NOT PLANNING A REVISION SURGERY TO TRY TO RETRIEVE THE BROKEN PIECE AT THIS TIME THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12786027 ↗InjuryDec 10, 2020Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION SUGGESTED FOR SPINAL THERAPY. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT 25MM OF THE TIP OF GEARSHIFT BROKE OFF ABOUT 80-90MM IN THE PATIENT¿S PELVIS AND HAD TO REMAIN IN THE PATIENT. THE SURGEON WAS USING THE GEARSHIFT PROPERLY AND WHEN HE PULLED IT OUT NOTICED A LARGE PORTION OF THE TIP WAS MISSING. X-RAY CONFIRMED THE BROKEN TIP WAS LODGED IN THE PATIENT¿S PELVIC BONE. THE BROKEN FRAGMENT WAS IN A ¿SAFE¿ LOCATION TOTALLY ENCAPSULATED BY BONE BUT WAS UNRETRIEVABLE WITHOUT CAUSING MORE HARM TO THE PATIENT. NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED. DEVICE WILL BE RETURNED. UPDATE; THERE IS NO PLAN TO REMOVE THE BROKEN TIP AND NO REVISION SURGERY PLANNED.
Patient problems: Foreign Body In Patient
MAUDE report 10981716 ↗
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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