CD HORIZON® Fenestrated Screw Set 55750025550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000149598), received between Jan 30, 2025 and Mar 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Backflow” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 12, 2025Backflow; Product Quality Problem; Backflow; Product Quality Problem

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS WAS SPINAL CANAL STENOSIS. IT WAS REPORTED THAT, ONE OF THE REPORTED SCREWS WAS USED AT L2. THE DELIVERY DEVICE ON THE LEFT SIDE OF L2 COULD NOT BE REMOVED BY TURNING IT BY HAND, AND IT CAME OFF WHEN THE DEVICE WAS GRASPED WITH PLIERS. THE CEMENT WAS FILLED ACCORDING TO THE IMAGE CHECK, BUT THE TIP CAME OFF THE TORX DUE TO SHAFT SHAKE, ETC. DURING THE PROCESS. THE CEMENT LEAKED INTO THE SCREW HEAD. THE TAB WAS REMOVED, AND THE TIP WAS COLLECTED USING A CHISEL, A LUER, AND PLIERS. THE ROD WAS EVEN BROUGHT TO A STATE WHERE IT CAN BE PUT ON. THE OTHER SCREW WAS USED AT L4, IT WAS OBSERVED THAT AN ABNORMAL CHANGE OCCURRED DURING CEMENT MANIPULATION, THE PUSHING ROD COULD NOT BE ADVANCED DUE TO THE TIGHTNESS DURING INJECTION OF CEMENT AT THE RIGHT L4 (PERCUTANEOUS PORTION). AT THAT STAGE, IT WAS MENTIONED TO WAIT AND CHECK, BUT THE PUSH STICK MOVED FORWARD WHILE CALLING OUT AND THE PUSHING STICK REMAINED IN PLACE. CEMENT LEAKAGE IN THE SCREW HEAD AT THE RIGHT SIDE OF L4 WHERE AN ABNORMALITY WAS FELT. IT WAS IDENTIFIED THAT THE PRODUCT WAS NOT FILLED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582542 ↗
• MalfunctionJan 30, 2025Backflow; Backflow

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THE CEMENT COULD NOT BE INSERTED PROPERLY AND LEAKED OUT AGAIN ABOVE THE SCREW HEAD. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272332 ↗