CD HORIZON® Fenestrated Screw Set 55750027555Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS MAS 55750027555 STER CCM 7.5 X 55 · 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
- 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 00763000149192), received between Feb 7, 2022 and Feb 7, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2022Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CEMENT IN AN AUGMENTATION PROCEDURE FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE CEMENT LEAKED INTO SCREW TULIP DUE TO CEMENTATION WITH VOYAGER SCREWS. SCREWS HAVE BEEN USED WITH AUGMENTATION PROCEDURE BUT THE CEMENT LEAKED OUT BETWEEN SCREW CRONE AND VOYAGER DISPOSABLE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS A DELAY OF 30 MINUTES IN THE SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13469687 ↗MalfunctionFeb 7, 2022Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CEMENT IN AN AUGMENTATION PROCEDURE FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE CEMENT LEAKED INTO SCREW TULIP DUE TO CEMENTATION WITH VOYAGER SCREWS. SCREWS HAVE BEEN USED WITH AUGMENTATION PROCEDURE BUT THE CEMENT LEAKED OUT BETWEEN SCREW CRONE AND VOYAGER DISPOSABLE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS A DELAY OF 30 MINUTES IN THE SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13469684 ↗
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.
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