CD HORIZON® Fenestrated Screw Set 55750026545Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000148836), received between Jun 22, 2023 and Sep 28, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Backflow” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Leak/Splash

  Information was received from the Health care professional via a manufacturer representative regarding a device used for L2-5 Lateral Lumbar Interbody Fusion, L2-L5 ercutaneous pedicle screw fixation, L2, L4, L5 Femoral Neck System procedures.The preoperative diagnosis for this surgery was L2/3/4/5 lumbar spinal canal stenosis with degenerative scoliosis.It was reported that during intra-op,when filling the cement, it felt harder than usual. During cement insertion on the right side of L2, there was a hard feeling, but imaging was also confirmed and filling was continued as is.Cement leakage was confirmed when the device was removed. Therefore, the right L2 screw was replaced with a standard MAS.After removal, it was confirmed that the cement had not reached the hole at the tip of the screw and that almost all of it had leaked into the head.The device had been inserted slightly obliquely, and the confirmation button was also in a state where it could be pressed slightly.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 50912801 ↗
• MalfunctionJul 30, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50082279 ↗
• MalfunctionJun 9, 2026Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3 BALLOON KYPH OPLASTY (BKP) FOR SECONDARY FRACTURE (COMPRESSION FRACTURE). IT WAS REPORTED THAT DURING THE INJECTION OF 0.8CC OF FNS CEMENT INTO THE RIGHT SIDE OF L2, EXTRA VERTEBRAL LEAKAGE WAS IDENTIFIED THROUGH INTRAOPERATIVE FLUOROSCOPY. POSTOPERATIVE CT IMAGING REVEALED THAT THE CEMENT HAD REACHED THE INFERIOR VENA CAVA. IT HAS BEEN CONFIRMED THAT THE PATIENT IS ASYMPTOMATIC AT THIS TIME; HOWEVER, AFTER CONSULTING WITH THE CARDIOLOGY DEPARTMENT, ANTICOAGULANT THERAPY WILL BE INITIATED TO PREVENT PULMONARY EMBOLISM. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO MALFUNCTION IS REPORTED WITH UNKNOWN VOYAGER IMPLANT. IT WAS ADDED TO THIS EVENT FOR A VERTEBRAL FRACTURE POST INITIAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE CEMENT LEAKED FROM THE VOYAGER FENESTRATED SCREW. THERE WERE NO MALFUNCTIONS WITH FNS TIPS AND BONE FILLER DEVICES. THEY WERE USED ALONG WITH FENESTRATED SCREW. THERE ARE NO DEFECTIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445333 ↗
• MalfunctionJul 16, 2025Backflow; Mechanical Jam; Backflow; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED IN SPINAL THERAPY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT TO PREVENT CEMENT LEAKAGE INTO THE SCREW HEAD, THE INLINE METHOD WAS USED TO CHECK FOR ANY AXIAL MISALIGNMENT, AND THE DELIVERY GUIDE WAS INSERTED. THE PASSAGE WAS CONFIRMED USING A 1.5K WIRE, AND UNDER THE C-ARM, THE FLOW OF CEMENT INTO THE VERTEBRAL BODY WAS VERIFIED. AFTER CEMENT FILLING, IT WAS CONFIRMED THAT THE TIP DID NOT COME OFF WHEN REMOVING THE DELIVERY GUIDE. ATTEMPTS WERE MADE TO REMOVE THE CEMENT USING A CHISEL AND DETACH THE TIP WITH A PUNCH, BUT THESE EFFORTS WERE ABANDONED. SINCE ATTENTION WAS PAID TO BOTH THE VISCOSITY AND THE FILLING SPEED OF THE CEMENT, THE CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED. THERE WAS A DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO EXTRAVASATION OF CEMENT IS OBSERVED. THERE IS NO ALLEGATION OF CEMENT BUT THIS EVENT IS REPORTED FOR SCREW MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518058 ↗
• 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 22469981 ↗
• MalfunctionMay 7, 2025Backflow; Backflow

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS PE DICLE SCREW (PPS) FIXATION THERAPY FOR L1 COMPRESSION FRACTURE. IT WAS REPORTED THAT THE CEMENT WAS REFILLED WITH FNS, BUT IT WAS NOT DELIVERED TO THE VERTEBRAL BODY AND LEAKED INTO THE SCREW HEAD. BOTH PLACES WERE RIGHT, TH12 AND L2. IT WAS NOT POSSIBLE TO OBTAIN THE FIXATION PROPERTIES THAT WERE ORIGINALLY EXPECTED. CEMENT REMAINED IN THE SCREW HEAD, MAKING IT IMPOSSIBLE TO INSTALL THE ROD. TH12 WAS REMOVED AND THE SCREW WAS RE-PLACED. L2 SEEMED TO HAVE BEEN ABLE TO REMOVE THE CEMENT AT FIRST GLANCE, BUT BECAUSE THE SET SCREW COULD NOT BE TIGHTENED COMPLETELY DUE TO THE REMAINING CEMENT NEAR THE CROWN, THE SET SCREW BURST OPEN DURING THE FINAL TIGHTENING, SO THE V5 TAB WAS COMPLETELY REMOVED AND THE ROD WAS RE-PLACED. THE SET SCREW DID NOT FIT INTO THE SCREW HEAD AND CAME LOOSE DURING THE FINAL FASTENING. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE. 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 21979117 ↗
• InjuryApr 1, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED VIA HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED IN BALLOON KYPHOPLASTY (BKP) PROCEDURE FOR MULTIPLE MYELOMA. TYPE OF FRACTURE WAS COMPRESSION FRACTURE. LEVEL AT WHICH IMPLANT WAS PERFORMED IS T11/L2 (L1BKP) AND L4BKP. IT WAS REPORTED THAT BALLOON ALONE WAS USED IN L4. L1 WAS FIXED WITH 2A-1B AFTER PERFORMING BKP. FNS WAS USED FOR T11/T12/L2, AND NORMAL SCREWS WERE INSERTED INTO L1. IT WAS OBSERVED THAT THERE WAS CEMENT EXTRAVASATION AND PATIENT HAD PULMONARY EMBOLISM WHICH RESULTED IN HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION. IT WAS ALSO SAID THAT CEMENT WAS NOT STORED ACCORDING TO APPROPRIATE TEMPERATURE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT DURING THE PROCEDURE, CEMENT LEAKAGE WAS NOT NOTICED, BUT IT WAS DISCOVERED IN POSTOPERATIVE EXAMINATIONS. LEAKAGE APPEARED TO OCCUR FROM THE SCREW ON THE RIGHT SIDE OF TH11. IT IS NOW ASYMPTOMATIC, WITH NO HEALTH DAMAGE AND WILL BE MONITORED THROUGH APPROPRIATE CONSERVATIVE TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE LEAKED CEMENT CAUSE

  Patient problems: Pulmonary Embolism

  MAUDE report 21736578 ↗
• 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 21582603 ↗
• InjuryMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREWS IN A POSTERIOR PEDICLE SCREW FIXATION WITH CEMENTED SCREWS AT L4/5 FOR BACK PAIN, RADICULAR SYMPTOMS. IT WAS REPORTED THAT THE LOCKING CAP OF THE FNS SCREW WAS TORQUED OFF AND THE BROKEN OFF PART WAS REMOVED. HOWEVER, THE LOCKING CAP HAS COME LOOSE AND IS FLOATING IN MUSCLE ABOVE THE CONSTRUCT. THE LOCKING CAP TORQUED OFF AS NORMAL. THE SURGEON FOLLOWED THE STEPS AS NORMAL AND INDICATED. THE FNS SCREW'S LOCKING CAP IS THE SUSPECTED ISSUE BUT THE SET SCREW WAS REPORTED AS WELL AS THE THREADS MAY BE DAMAGED IN THAT TOO. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19246559 ↗
• InjuryJun 22, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED SCREWS. IT WAS REPORTED THAT, PATIENT HAD L5/S1 POSTERIOR LUMBAR FIXATION IN (B)(6) 2021. PATIENT COMPLAINED OF PAIN IN (B)(6) 2022, AND RADIOLOGICAL REPORTS HIGHLIGHTED A PEDICLE BREACH AT L5 WITH NO APPARENT IMPLANT FAILINGS. REVISION WAS PERFORMED ON (B)(6) 2023 AND DURING THE PROCEDURE IT WAS FOUND THAT THE S1 SCREW HAD BROKEN AND PARTIALLY EXPLANTED AND L5 SCREW WAS REPLACED. THE BROKEN FRAGMENT WAS LEFT INSIDE THE BONE AND SURGERY WAS ABANDONED FOR A REVISION AT A LATER DATE. THERE WAS NO PATIENT SYMPTOM REPORTED AS A RESULT OF BROKEN SCREW. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED. THE L5 SCREW HAD BREACHED THE PEDICLE. DURING THE PROCEDURE TO REPLACE THE L5 SCREW, IT BECAME APPARENT THAT THE S1 SCREW HAD BROKEN. IT IS UNCLEAR WHEN THIS SCREW FRACTURED. THE MRI SCAN IDENTIFIED THE BREACH IN (B)(6) 2022 SHOWED THAT THE L5 SCREW HAD BREACHED THE PEDICLE BY BEING INFERIOR AND MEDIAL IN THE PEDICLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17180580 ↗