CD HORIZON® Fenestrated Screw Set 55850026540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000146160), received between Jul 21, 2020 and Jul 6, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Backflow” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2023Backflow; Backflow

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS SP INAL FIXATION FOR SPINAL FRACTURE. IT WAS REPORTED THAT WHEN THE CEMENT WAS READY TO BE USED, THE CEMENT DELIVERY GUIDES WITH DISPOSABLE TIPS WERE PLACED ON THE SCREWS AS PER THE SURGICAL TECHNIQUE. THE CEMENT DELIVERY DEVICE WAS THEN PLACED IN THE GUIDE AND THE CEMENT WAS DELIVERED WITH THE GUN. CEMENT COULD NOT BE VISUALIZED ENTERING THE VERTEBRAL BODY. THE DECISION WAS MADE TO MOVE ON TO THE NEXT SCREW WITH SIMILAR RESULTS. THE GUIDES AND TIPS WERE LEFT IN PLACE FOR 3 MIN AFTER CEMENT DELIVERY. WHEN AN ATTEMPT WAS MADE TO REMOVE THE GUIDES THE TIPS WERE STUCK IN THE HEAD OF THE SCREWS. WHILE TRYING TO REMOVE THE TIPS, IT BECAME CLEAR THAT THE CEMENT DID NOT GO DOWN THE SCREW INTO THE VERTEBRAL BODY, BUT SPILLED OUT INTO THE HEAD OF THE SCREWS AND AROUND THE SCREWS. MOST OF THE CEMENT ENDED UP IN THE HEAD OF THE SCREWS AND AROUND THE SCREW HEADS AND HAD TO BE REMOVED. CEMENT EXTRAVASATION WAS DETECTED INTRA-OPERATIVELY. THERE WAS A DELAY TO THE TOTAL PROCEDURE TIME OF MORE THAN 1 HOUR. THE PERCUTANEOUS PROCEDURE HAD TO BE CHANGED MID CASE TO A OPEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17264452 ↗
• InjuryJul 21, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE; AND UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION AT L4-S1 WITH PERCUTANEOUS FENESTRATED SCREW POSTERIORLY. INTRA-OP, THE LEFT L5 SCREW ASSEMBLY DID NOT LET CEMENT BE INJECTED THROUGH THE SCREW AND ALLOWED CEMENT TO ESCAPE AROUND THE CEMENT DELIVERY SYSTEM GUIDE, FENESTRATED TIP, TULIP, AND EXTENDER TABS. THE PATIENT HAD TO BE UNDER ANESTHESIA FOR A LONGER TIME AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 10304756 ↗