CD HORIZON® Fenestrated Screw Set 55750027540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000149161), received between Mar 21, 2025 and Jan 5, 2026 — classified as 2 injuries, 4 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Backflow

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR VERTE BRAL FUSION AT 9TH THORACIC VERTEBRA - PELVIS (LEFT S1). PRE OP DIAGNOSIS WAS PSEUDARTHROSIS FOLLOWING FOURTH LUMBAR VERTEBRA COMPRESSION FRACTURE, FIFTH LUMBAR VERTEBRA AND SIXTH LUMBAR VERTEBRA COMPRESSION FRACTURES. IT WAS REPORTED THAT DURING SCREW INSERTION, CEMENT INJECTION PROCEDURE WAS PERFORMED USING THIS PRODUCT ON THE LEFT S1. CEMENT WAS INJECTED INTO THE VERTEBRAL BODY WITHOUT ISSUE UP TO APPROXIMATELY 1.6 CC, BUT WHEN INJECTING THE FINAL 0.2 CC, A SHADOW WAS OBSERVED AROUND THE SCREW HEAD ON THE X-RAY IMAGE, AND DIRECT VISUALIZATION CONFIRMED A SMALL AMOUNT OF CEMENT LEAKAGE. THE LEAKED CEMENT WAS REMOVED AS MUCH AS POSSIBLE, AND THIS DID NOT INTERFERE WITH THE SUBSEQUENT PROCEDURE. IT WAS CONSIDERED THAT THE ISSUE IS NOT DUE TO A DEFECT IN THE CEMENT ITSELF. IT WAS UNABLE TO BE DETERMINED WHETHER LEAKAGE WAS DUE TO BACKFLOW WITHIN THE SCREW OR LEAKAGE FROM THE TIP. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959874 ↗
• MalfunctionJan 5, 2026Malposition of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT WHEN 0.8CC OF CEMENT WAS INJECTED FROM ONE SIDE INTO T10, IT WAS NOTICED THAT THE CEMENT HAD LEAKED, SO A CT SCAN WAS PERFORMED IMMEDIATELY. THE CEMENT APPEARED TO HAVE SPREAD HORIZONTALLY ACROSS THE ANTERIOR SURFACE OF THE VERTEBRAL BODY, POSSIBLY SEGMENTALLY. IT DID NOT REACH ANY MAJOR BLOOD VESSELS.NO ADDITIONAL CEMENT WAS INJECTED; THE WOUND WAS CLOSED AFTER ROD IMPLANTATION. THERE WAS NO ISSUE WITH THE SCREW ITSELF; IT WAS SUSPECTED THAT THERE ISAN ISSUE WITH SCREW PLACEMENT POSITION. 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 23959075 ↗
• 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 22470290 ↗
• 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 22470143 ↗
• MalfunctionJun 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/4/5 VERTEBRAL COLUMN RESECTION/ SPINE FUSION (VCR/PF) THERAPY FOR L4 RUPTURE FRACTURE. IT WAS REPORTED THAT CEMENT WAS INJECTED AFTER DEVICE PLACEMENT (WITH PROPER VISCOSITY ACHIEVED 15 MINUTES AFTER MIXING). THERE WAS SLIGHT LEAKAGE ON THE LEFT SIDE OF L5, CAUSING THE TIP TO ADHERE. ALTHOUGH THE ADHERED PORTION WAS REMOVED USING A CHISEL, SCREW LOOSENING WAS OBSERVED, LEADING TO A SIZE ADJUSTMENT. AFTERWARD, THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS A DELAY OF LEE THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO ALLEGATION AGAINST TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22217436 ↗
• MalfunctionMar 21, 2025Backflow; Backflow

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2 BKP (BALLOON KYPHOPLASTY) TH12/L3 POSTERIOR FIXATION THERAPY FOR PRIMARY OSTEOPOROSIS AND L2 COMPRESSION FRACTURE. IT WAS REPORTED THAT BKP AND PS WERE INSERTED INTO L2. AFTER THAT, INSERTED L1 PS, BUT IT WAS NOT VERY EFFECTIVE, SO CHANGED THE FIXED RANGE TO TH12. FM WAS PERFORMED ON TH12 AND L3. AFTER FILLING THE CEMENT, THE DELIVERY GUIDE WAS REMOVED, BUT THE TIP ON BOTH SIDES OF TH12 REMAINED INSIDE THE HEAD. ON THE LEFT SIDE, THE DELIVERY GUIDE WAS REINSERTED AND RE-ATTACHMENT AND REMOVAL WERE POSSIBLE, BUT ON THE RIGHT SIDE, IT DID NOT COME OFF AT ALL. IT COULD NOT BE PERFORMED USING ANY TOOL THAT CAN GRASPED OR KOCHER FORCEPS. THE TAB TRIED FOLDED ON ONE SIDE AGAIN BUT IT DID NOT WORK. THE TABS WAS FOLDED ON BOTH SIDES AND TRIED TO GRAB IT WITH PLIERS IN THE MINI-OPEN STATE AND PULL IT OUT, BUT IT WAS IMPOSSIBLE. AFTERWARDS, CEMENT WAS FOUND AROUND THE TIP (INSIDE THE HEAD). THEREFORE, THE PROCESS OF SCRAPING AND PULLING WITH A CHISEL IS REPEATED MANY TIMES. MORE THAN 40 MINUTES HAVE PASSED SINCE THE REMAIN WAS CONFIRMED IN THE TIP. AFTER THAT, WITH MOST OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663180 ↗