CD HORIZON® Fenestrated Screw Set 55750027545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000149178), received between Jun 9, 2026 and Jun 9, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. 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.

• MalfunctionJun 9, 2026Leak/Splash

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR L3 & L5 PERCUTANEOUS PEDICLE SCREWS SPINAL THERAPY FOR 1A1B FUSION AND L4 VERTEBRAL BODY REPLACEMENT FOR L4 RUPTURED FRACTURE. IT WAS REPORTED THAT THE CEMENT WAS INJECTED INTO THE FM OF L5, BUT IT LEAKED FROM THE SCREW HEAD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED PRODUCTS ARE RELATED TO THE CEMENT LEAK FROM THE SCREW HEAD. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE RECEIVED OTHER PRODUCTS EXTENDERS WERE IN AN ASSEMBLED STATE, AND NO DAMAGE WAS OBSERVED ON ITS EXTERIOR. HOWEVER, CEMENT LEAKAGE WAS CONFIRMED NEAR THE CEMENT DELIVERY GUIDE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445841 ↗
• MalfunctionJun 9, 2026Leak/Splash

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR L3. L5 PERCUTANEOUS PEDICLE SCREWS SPINAL THERAPY FOR 1A1B FUSION AND L4 VERTEBRAL BODY REPLACEMENT FOR L4 RUPTURED FRACTURE. IT WAS REPORTED THAT THE CEMENT WAS INJECTED INTO THE FM OF L5, BUT IT LEAKED FROM THE SCREW HEAD. THEREWERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED PRODUCTS ARE RELATED TO THE CEMENT LEAK FROM THE SCREW HEAD. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE RECEIVED OTHER PRODUCTS EXTENDERS WERE IN AN ASSEMBLED STATE, AND NO DAMAGE WAS OBSERVED ON ITS EXTERIOR. HOWEVER, CEMENT LEAKAGE WAS CONFIRMED NEAR THE CEMENT DELIVERY GUIDE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445663 ↗