CD HORIZON® Fenestrated Screw Set 55750025540Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000149574), received between Feb 16, 2021 and Aug 8, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LOW BACK FIXATION PROCEDURE FOR AN INDICATION OF LOW BACK AND RADICULAR SYMPTOMS. IT WAS REPORTED THAT THE PEDICLE SCREW WAS BROKEN POST-OPERATIVELY, AND THE BROKEN SCREW SHAFT REMAINS IMPLANTED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748416 ↗
• MalfunctionJul 14, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LOW BACK FIXATION PROCEDURE FOR AN INDICATION OF LOW BACK AND RADICULAR SYMPTOMS. IT WAS REPORTED THAT THE PEDICLE SCREW WAS BROKEN POST-OPERATIVELY, AND THE BROKEN SCREW SHAFT REMAINS IMPLANTED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491489 ↗
• InjuryJul 10, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING TRANSCUTANEOUS POSTERIOR FIXATION USING A CEMENT SCREW WITH 2A-2B FOR DISH FRACTURE AND COMPRESSION FRACTURE AND TRANSCUTANEOUS VERTEBROPLASTY USING BKP AT LEVELS T9-L2. IT WAS REPORTED THAT POST SURGERY, THE CEMENT LEAKED INTO THE VEIN AND FLOWED INTO THE PULMONARY ARTERY. THIS WAS DISCOVERED AFTER THE PROCEDURE, AND THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF DISCOVERY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE MIXER HAD NO MALFUNCTION. REGARDING THE KITS AND SCREWS, THERE WAS A SMALL POSSIBILITY THAT THEY MAY HAVE CAUSED THE CEMENT LEAKAGE BUT THIS WAS NOT CONFIRMED. THERE WAS NO CHANGE IN THE PATIENT'S CONDITION AND NO ADDITIONAL TREATMENT OR PROCEDURE IS BEING PERFORMED AS A RESULT OF THIS EVENT. BUT THE PATIENT WAS FOUND TO HAVE STOMACH CANCER WHILE HE WAS IN THE HOSPITAL (WAITING FOR RECOVERY), AND THAT HE WOULD PERFORM A GASTRIC CANCER OPERATION WHICH WAS UNRELATED TO THIS EVENT. THEREFORE, IT IS UNKNOWN WHETHER HE HAS RECOVERED OR NOT. ADDITIONAL INFORM

  Patient problems: Pulmonary Embolism

  MAUDE report 22470233 ↗
• InjuryJul 10, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING TRANSCUTANEOUS POSTERIOR FIXATION USING A CEMENT SCREW WITH 2A-2B FOR DISH FRACTURE AND COMPRESSION FRACTURE AND TRANSCUTANEOUS VERTEBROPLASTY USING BKP AT LEVELS T9-L2. IT WAS REPORTED THAT POST SURGERY, THE CEMENT LEAKED INTO THE VEIN AND FLOWED INTO THE PULMONARY ARTERY. THIS WAS DISCOVERED AFTER THE PROCEDURE, AND THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF DISCOVERY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE MIXER HAD NO MALFUNCTION. REGARDING THE KITS AND SCREWS, THERE WAS A SMALL POSSIBILITY THAT THEY MAY HAVE CAUSED THE CEMENT LEAKAGE BUT THIS WAS NOT CONFIRMED. THERE WAS NO CHANGE IN THE PATIENT'S CONDITION AND NO ADDITIONAL TREATMENT OR PROCEDURE IS BEING PERFORMED AS A RESULT OF THIS EVENT. BUT THE PATIENT WAS FOUND TO HAVE STOMACH CANCER WHILE HE WAS IN THE HOSPITAL (WAITING FOR RECOVERY), AND THAT HE WOULD PERFORM A GASTRIC CANCER OPERATION WHICH WAS UNRELATED TO THIS EVENT. THEREFORE, IT IS UNKNOWN WHETHER HE HAS RECOVERED OR NOT. ADDITIONAL INFORM

  Patient problems: Pulmonary Embolism

  MAUDE report 22470216 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR VERTEBRAL COMPRESSION DUE TO PYOGENIC SPONDYLITIS, PPS FIXATION AFTER INFLAMMATION AND CALMING. IT WAS REPORTED THAT CEMENT SCREWS WERE USED FOR TH9, 10, L1, AND L3. AFTER SCREW INSERTION, CEMENT WAS MIXED, CEMENT WAS REFILLED FROM THE LUMBAR VERTEBRA LEVEL AND 1.8 CC OF ALL LUMBAR VERTEBRA WAS FILLED. AFTERWARDS, THE CEMENT WAS STARTED FILLING AT THE THORACIC VERTEBRAE LEVEL AND FINALLY MANAGED TO COMPLETE THE FILLING WITH A VISCOSITY THAT WAS DIFFICULT TO PUSH OUT THE CEMENT. ALL CEMENTS ARE SPREAD INTO THE VERTEBRAL BODY, AND THERE WAS NO LEAKAGE FROM THE SCREW HEAD, SO IT WAS USED PROPERLY. THEN THE ROD WAS SIZING AND CUT UNTIL 3 MINUTES AFTER THE FINAL REFILL TO COMPLETE CURING, THE CEMENT DEVICE WAS REMOVED AFTER BENDING, AND WHEN THE ROD WAS BEING INSERTED, THE PATIENT'S CONDITION WORSENED, THE SATURATION WAS REDUCED, AND THE A-LINE COULD NOT BE REMOVED. THE INSERTION OF THE ROD WAS ABANDONED, THE TAB WAS FOLDED AND THE POSITION WAS CHANGED; AROUND THIS AREA, CARDIAC ARREST OCCURRED AND CARDIAC MASSAGE WAS PERFORMED. THE PATIENT MANAGED TO R

  Patient problems: Cardiac Arrest; Loss of consciousness

  MAUDE report 22050668 ↗
• InjuryMay 2, 2025Backflow; Leak/Splash; Backflow; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2 POSTERIOR SP INAL FUSION FOR AN INDICATION OF TH12 VERTEBRAL FRACTURE. IT WAS REPORTED THAT DURING CEMENT INJECTION INTO THE L2 FSN, THE CEMENT WAS LEAKED TO THE BLOOD VESSEL-LIKE SITE OUTSIDE THE VERTEBRAL BODY. THE CEMENT WAS CONFIRMED IN THE IN THE RIGHT ATRIUM IN THE POSTOPERATIVE CT. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. THE ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 AND A DRY SHEATH AND A SNARE CATHETER WERE INSERTED THROUGH THE NECK TO REMOVE CEMENT THAT HAD ENTERED THE RIGHT ATRIUM. AS FOR THE CEMENT AROUND THE SPINE, IT IS UNLIKELY THAT IT WILL BE REMOVED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Extravasation

  MAUDE report 21948901 ↗
• MalfunctionFeb 16, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF VERTEBRA FRACTURE. IT WAS REPORTED THAT THE CEMENT LEAK OUT INTO SCREW HEAD INSTEAD OF COMING OUT AT FENESTRATED SCREW HOLES. IT HAPPENED IN TWO SCREWS. THE CEMENT WAS LEAKED AT THE POSTERIOR PART OF THE VERTEBRA AND THE SURGEONS WAS ABLE TO REMOVE IT DURING SURGERY. THE PROCEDURE ENDED WITHOUT ANY INJURY TO THE PATIENT. THERE WAS DELAY OF 30MIN IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE IS NO ADDITIONAL SURGERY PLANNED. TYPE OF PROCEDURE IS PLIF WITH VOYAGER WITH LORDORSIS CORRECTION AND LIGAMANETOTAXIS.

  Patient problems: Extravasation

  MAUDE report 11331973 ↗