CD HORIZON® Fenestrated Screw Set 55750025545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS MAS 55750025545 STER CCM 5.5 X 45 · 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 00763000149581), received between Jul 13, 2026 and Jul 13, 2026 — 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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2026Material Twisted/Bent
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT UNDERWENT T12 VERTEBROPLASTY + T11¿L1 PERCUTANEOUS PEDICLE SCREW (PPS) FIXATION REVISION SURGERY FOR EXTENSION. IT WAS REPORTED THAT CURRENTLY T9-L1 WAS FIXED, BUT THE RIGHT L1 FENESTRATED SCREW BROKE BELOW THE SCREW HEAD. THE LEFT L1 FENESTRATED SCREW IS BENT. REOPERATION IS SCHEDULED FOR EXTENDING TO L2 AND L3. THE TIP OF THE SCREW IS PLANNED TO REMAIN IN PLACE. ADDITIONAL SCREWS WERE PLACED AT L2 AND L3, AND FIXATION WAS COMPLETED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT REOPERATION WAS PERFORMED FOR THE ADJACENT SEGMENT DISORDER. SCREWS WERE ADDED AT TH9 AND TH10, AND FIXATION WAS EXTENDED. AFTER THAT, SCREW FRACTURE AND BENDING OCCURRED. THE ADJACENT SEGMENT DISORDER OCCURRED AT VOYAGER IMPLANT AND NO IMPLANT MALFUNCTION WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO PLAN TO REMOVE THE IMPLANT. IT IS UNKNOWN FOR THE CAUSE OF ADJACENT SEGMENT DISEASE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25793358 ↗
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- 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.
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