CD HORIZON® Fenestrated Screw Set 55751026545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000150891), received between Nov 26, 2024 and Jul 31, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBRAL BODY REDUCTION FOR L1 BURST FRACTURE (T11 TO L1 FIXATION) IT WAS REPORTED THAT THE SCREWS WERE BROKEN. THE BROKEN SCREW HEAD CAME IN CONTACT WITH THE SKIN, AND IT CAUSED BACK PAIN. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025. DURING THE INITIAL SURGERY, 11 WAS FIXATED TO L1. VF WAS USED TO PERCUTANEOUSLY REDUCE THE VERTEBRAL BODY. THE PATIENT WAS INSTRUCTED TO WEAR A CORSET AND REST FOR 3 MONTHS AFTER THE SURGERY. THE STATUS OF COMPLIANCE IS UNKNOWN. THE PATIENT COMPLAINED OF BACK PAIN STARTING FROM THE 4TH MONTH; UPON IMAGE EVALUATION, A CORRECTION LOSS WAS OBSERVED, AND A SHAFT FRACTURE WAS CONFIRMED IN THE RIGHT SIDE OF THE HEAD SCREW AND THE LEFT SIDE OF THE CAUDAL SCREW. IT WAS CONFIRMED THAT THE SHAFT WAS BROKEN ON THE RIGHT SIDE OF THE HEAD SCREW AND THE LEFT SIDE OF THE CAUDAL SCREW. THE SHAFT AND SCREW HEAD WERE ALSO REMOVED USING THE REMOVABLE KIT. THERE WAS NO PATIENT INVOLVEMENT/SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Back pain

  MAUDE report 22673414 ↗
• MalfunctionNov 26, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING PPS SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW WAS LOOSE WHEN ATTEMPTING TO TIGHTEN THE ROD. ONCE THE SCREW WAS CHECKED FOR LOOSENESS, IT WAS REPLACED, TAKING INTO CONSIDERATION THE RISK OF LOOSENING AFTER SURGERY. 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 20778790 ↗