CD HORIZON® Fenestrated Screw Set 55750024535Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS MAS 55750024535 STER CCM 4.5 X 35 · Class 2 · Implant
- 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 00763000149321), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
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.
MalfunctionDec 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION USING 2 ABOVE 2 BELOW PROCEDURE WAS PERFORMED FOR A VERTEBRAL FRACTURE AT TH8 DUE TO DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS (DISH). IT WAS REPORTED THAT DURING PROCEDURE, BONE CEMENT LEAKAGE WAS DETECTED INTRAOPERATIVELY INTO THE BLOOD VESSEL AT THE RIGHT TH7 AND RIGHT TH6 LEVELS, AND POSSIBLE LEAKAGE TOWARD THE POSTERIOR SIDE AT LEFT TH6 WHILE FILLING EACH VERTEBRAL BODY AND THE FILLING WAS STOPPED IMMEDIATELY UPON DETECTION, MINIMIZING THE EXTENT OF LEAKAGE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE OPINION AT THE END OF THE OPERATION WAS THAT THE TH6 LEFT SCREW WAS INSERTED FROM THE OUTSIDE AND THE CEMENT FLOWED LATERALLY, BUT AFTER THE OPERATION, THE CT REVEALED THAT THE SCREW WAS OUT OF BOUNDS IN THE INTERIOR AND THAT THE CEMENT HAD LEAKED INTO THE SPINAL CANAL. THERE IS NO OTHER PROBLEM WITH THE PATIENT AT THIS STAGE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN¿S POSTOPERATIVE ASSESSMENT WAS INCORRECT. AT THE TIME OF THE A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23714446 ↗
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
- iVAS 0705315000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- Cortoss 2101-0005Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- iVAS 0705310000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.