CD HORIZON® Spinal System 25740018510Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 25740018510 BS CNMAS 8.5X100 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169414846), received between Apr 3, 2019 and Nov 18, 2024 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Muscle Weakness/Atrophy1
- Muscular Rigidity1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
Additional information was received that Outcome Status: Resolved Outcome Date (b)(6)2024
Patient problems: Muscle Weakness/Atrophy; Muscular Rigidity; Pain
MAUDE report 20707745 ↗MalfunctionApr 3, 2019Break; Break
PRE-OPERATIVE DIAGNOSIS: STENOSIS, T10-PELVIS WITH POSSIBLE PSO (POLYCYSTIC OVARY SYNDROME) LEVELS IMPLANTED: S2 ALAR SCREW IT WAS REPORTED THAT INTRA-OP, THE SURGEON IMPLANTED A SCREW. ON REMOVAL OF THE SCREW THE SURGEON NOTICED THAT THE PIN WAS STICKING OUT OF THE HEAD OF THE SCREW. THE SCREW WAS BROKEN BUT NO FRAGMENT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8477608 ↗
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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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