CD HORIZON® Fenestrated Screw Set 55751025550Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS SAS 55751025550 STER CCM 5.5 X 50 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000150600), received between Jun 12, 2026 and Jun 12, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
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.
InjuryJun 12, 2026Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION SPINAL THERAPY FOR L1 BURST FRACTURE. IT WAS REPORTED THAT AFTER FIXATION FROM T11/12 TO L2/3, THE L2/3 SCREW BACKED OUT SO THE L2/3 SCREW WAS REPLACED, AND ADDITIONAL SCREWS WERE INSERTED AT T10 AND L4 FOR REFIXATION. ACCORDING TO THE OPINION OF THE SURGEON, THE PATIENT¿S BONE DENSITY WAS BELOW 50. THE PHYSICIAN COMMENTED THAT THE INITIAL SURGICAL PLANNING WAS INSUFFICIENT. BECAUSE THE BONE WAS FRAGILE, IT WAS CONSIDERED UNAVOIDABLE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE INITIAL SURGERY WAS PERCUTANEOUS PEDICLE SCREW: T11/12¿L2/3: L1 BURST FRACTURE VERTEBROPLASTY WAS PERFORMED. FOUR SCREWS AT L2/3 HAD BACKED OUT AND THE FOUR SCREWS WERE UPSIZED AND THE HA STICKS WERE REPLACED. FIXATION WAS EXTENDED TO T10¿L4, RESULTING IN A 3¿3 FIXATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481456 ↗
Other CEMENT, BONE, VERTEBROPLASTY devices
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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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