CD HORIZON® Fenestrated Screw Set 55751025540Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS SAS 55751025540 STER CCM 5.5 X 40 · Class 2 · Implant
All models of CD HORIZON Fenestrated Screw Set (27)
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 00763000150587), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2025Material Twisted/Bent; Material Twisted/Bent
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD POSTERIOR FIXATION FOR L1 VERTEBRAL FRACTURE. IT WAS REPORTED THAT WHEN ATTEMPTING TO USE A TAB EXTENDER AND CAP WITH THE SCREW, A BEND IN THE TAB WAS NOTICED, SO IT WAS REPLACED WITH ANOTHER ONE. THE EVENT OCCURRED AT BACK TABLE DURING INITIAL SETUP. THE TAB WAS BENT OUT OF BOX. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749436 ↗
Other CEMENT, BONE, VERTEBROPLASTY devices
- CONFIDENCE SPINAL CEMENT SYSTEM 283910000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY5 deaths163 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283913000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY8 deaths146 reports
- KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01BMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY3 deaths67 reports
- SYNFLATE 03.804.701SSynthes GmbH · CEMENT, BONE, VERTEBROPLASTY60 reports
- KYPHON® HV-R® Bone Cement C01AMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY57 reports
- Cortoss 2101-0005Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- iVAS 0705315000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- Cortoss 2101-0010Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page