CD HORIZON® Fenestrated Screw Set 55750026550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000148843), received between Aug 21, 2023 and Sep 16, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Break

  Information was received from the Healthcare professional via a manufacturer representative regarding a device used for spinal therapy. It was reported that the patient was treated with a Spondylodese Transforaminal Lumbar Interbody Fusion at 16.4.26 at segment L5/S1, with Voyager and Capstone Cage. The patient returned for a follow-up examination in July and reported pain; an X-ray taken at the clinic revealed that the 6.5 x 50 mm screw at S1 (left side) was broken. The screw was removed and replaced with a new one on (b)(6), 2026. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: Pain

  MAUDE report 50782904 ↗
• MalfunctionMar 28, 2025Backflow; Backflow

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. LEVEL AT WHICH THE IMPLANT WAS PERFORMED WAS L5. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS L4 VERTEBRAL FRACTURE. IT WAS REPORTED THAT THE CEMENT LEAKED FROM THE SCREW HEAD AND THE CEMENT DELIVERY GUIDE TIP. THE SCREW WAS EXPLANTED AT THE SAME TIME AND THE SAME SIZE WAS INSERTED AGAIN. THERE WAS A LESS THAN 60 MINUTES DELAY IN THE OVERALL PROCEDURE TIME. 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 THERE WERE NO MALFUNCTION ON BONE FILLER (6550102) ITSELF, HOWEVER, IT WAS REPORTED BECAUSE IT WAS CONTACTED AT THE TIME OF THE CEMENT LEAK. THE TYPE OF PROCEDURE INVOLVED DURING THE EVENT WAS POSTPARTUM STERILIZATION (PPS) IN THE LATERAL DECUBITUS POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717669 ↗
• InjuryMar 27, 2025Backflow; Backflow

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A-VERTEBRAL COL UMN RESECTION, ANTERIOR POSTERIOR FUSION AT TH12-L4 DUE TO L2 VERTEBRAL BODY COMPRESSION.. IT WAS REPORTED THAT THE CEMENT WAS LEAKED FROM THE NEAR HEAD AREA ON BOTH SIDES OF THE L3 SCREWS. THE HEAD BECAME LOCKED WITH CEMENT, AND THE SCREW WAS REMOVED USING A COUNT ER. LATER, THE SCREW WAS REINSERTED AFTER SIZING UP. AS A RESULT, THERE WAS A DELAY OF MORE THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME AND ADDITIONALLY EXTENSION TO LOWER VERTEBRAL BODY WAS ALSO PERFORMED. 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 21705086 ↗
• InjurySep 20, 2024Break; Device Handling Problem; Break; Device Handling Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREW H AVING T11 - L3 REPAIR OF BURST FRACTURE THERAPY. IT WAS REPORTED THAT PATIENT HAD PRESENTED IN CLINIC WITH BACK PAIN AND A LUMP ABOVE THE STAB INCISION. FOLLOWING ANTIBIOTICS, PAIN AND LUMP WAS STILL VISIBLE AND X-RAY CONFIRMED THAT TAB WAS STILL ATTACHED TO THE SCREW HEAD. AS PER SURGEON, WHEN DR BROKE THE TOWERS IT SNAPPED OFF HALF OF THE TAB HEAD. VOYAGER SCREW TAB WAS LEFT IN PATIENT. TWO FULL EXTENDER TABS (NOT SCREW TAB) WERE LEFT INSIDE THE PATIENT AND WAS NOT BROKEN OFF FROM THE VOYAGER SCREW HEAD. SURGEON REOPERATED ON THE PATIENT ON (B)(6) 2024. PATIENT HAD SUCCESSFUL REMOVAL OF 2 TABS ON T11. PRODUCT WAS NOT USED CORRECTLY ACCORDING TO THE IFU/LABELING. PATIENT HAD REPORTED INFECTION AND PAIN AS A RESULT OF THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20266733 ↗
• InjuryAug 21, 2023Break; Malposition of Device; Break; Malposition of Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. IT WAS REPORTED THAT BOTH S1 SCREWS (RIGHT AND LEFT) WERE BROKEN. THE PRODUCTS WERE EXPLANTED BUT THE TIPS REMAINED INSIDE THE PATIENT. IT WAS A REVISION CASE. THE PATIENT HAD PSEUDARTHROSIS AND A SCREW WAS IN THE CANAL FOR THIS REASON, THE PATIENT WAS OPERATED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17584208 ↗