CD HORIZON® Spinal System 7570955Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885074457567), received between Jun 23, 2017 and Jun 10, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 16, 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.

• MalfunctionJun 10, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT IMPLANTED WITH SCREW AND SET SCREW HAVING L4-5 HEMILAMINECTOMY FOR NERVE ROOT DECOMPRESSION AND L4-L5 FUSION THROUGH THE TRANSFORAMINAL APPROACH (MIS-TLIF) THERAPY FOR L4-L5 DISC HERNIATION WITH NERVE ROOT COMPRESSION. IT WAS REPORTED THAT AFTER TIGHTENING THE SET SCREWS AND RECHECKING WITH C-ARM FLUOROSCOPY, TWO SCREW HEADS BECAME DETACHED FROM THE TWO SCREW SHAFTS. THE REPORTED EVENT WAS IDENTIFIED INTRAOPERATIVELY ON C-ARM RECHECK, AND THE INVOLVED PRODUCTS WERE EXPLANTED. 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 25454623 ↗
• MalfunctionDec 10, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT FOLLOWING A MAST (MINIMAL ACCESS SPINAL TECHNOLOGIES) PROCEDURE UTILIZING THE SEXTANT SYSTEM, IN WHICH FOUR SCR EWS WERE IMPLANTED, THE TULIP OF ONE SCREW BROKE AND SEPARATED FROM THE BODY POST-IMPLANTATION AFTER A MONTH. THE EVENT OCCURRED POST-OPERATIVELY AND RESULTED IN PAIN FOR THE PATIENT. A FRAGMENT OF THE IMPLANT REMAINS IN THE PATIENT. AN X-RAY WAS PLANNED FOR 15 DAYS POST-OPERATIVELY TO DETERMINE THE PRE-OPERATIVE DIAGNOSIS, AND RADIOGRAPHIC IMAGESWERE MADE AVAILABLE. NO ADDITIONAL SURGERY OR T REATMENT WAS PERFORMED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TYPE OF PROCEDURE/THERAPY INVOLVED DURING THE EVENT WAS MINIMALLY INVASIVE SPINE SURGERY (MIS). SURGEON HAS KEPT THE PATIENT ON OBSERVATION FOR ONE MONTH AND WILL BE GOING FOR A RESCAN. POST THAT SCAN WILL DECIDE ON THE NEXT STEPS.

  Patient problems: Pain

  MAUDE report 23766687 ↗
• InjuryJul 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN L1 -L3 PERCUTANEOUS MIS PROCEDURE IN A PATIENT DIAGNOSED WITH L2 BURST FRACTURE. IT WAS REPORTED THAT AFTER THE SURGERY DURING FOLLOW UP WITH THE PATIENT, IMPLANT BREAKAGE WAS NOTICED. REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN SCREWS AND STABILIZE THE L1 - L3 AGAIN. 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 15127849 ↗
• InjuryJan 18, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SET SCREWS LOOSENED AND DISLOCATED DUE TO WHICH A REVISION SURGERY WAS PERFORMED. IT WAS REPORTED THAT THE L5 AND S1 SCREWS ON BOTH SIDES LOOSENED ON (B)(6) 2017. ON (B)(6) 2017: WOUND INFECTION AND LOOSENING OF THE SET SCREW L5 AND S1 LEFT AND S1 RIGHT SIDE. ON (B)(6) 2017: WOUND INFECTION AND LOOSENING OF THE SET SCREW L5 AND S1 ON BOTH SIDES. ON (B)(6) 2017: LOOSENING OF THE SET SCREW L5 AND S1 ON BOTH SIDES, REMOVAL OF THE SCREWS L5 AND S1 AND RE-INSTRUMENTATION OF L5 AND S1. THE FIRST LOOSENING OF A SET SCREW AT ALL RECOGNIZED IN A CT SCAN ON (B)(6) 2016: SCREW L5 LEFT CONSEQUENTLY THE BI-SEGMENTAL INSTRUMENTATION (L3-L5) WAS ENLARGED TO L2-S1 ON (B)(6) 2017. THEN THE POSTOPERATIVE CT SCAN SHOWED A CHANCE FRACTURE OF L 1 ABOVE THE INSTRUMENTATION WHEREUPON THE INSTRUMENTATION WAS AGAIN ENLARGED UP TO T11 ((B)(6) 2017). IN THE FURTHER COURSE THE PATIENT WAS DISCHARGED AND WAS FOLLOWED UP IN OUR OUTPATIENT CLINIC AT THE END OF (B)(6) 2017. THE L5 SCREWS WERE IMPLANTED ON (B)(6) 2016. THE S1 SCREWS WERE IMPLANTED ON (B)(6) 2017. THE SCREWS WERE REMOVED ON (B)(6) 2017.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7202959 ↗
• InjuryJan 18, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SET SCREWS LOOSENED AND DISLOCATED DUE TO WHICH A REVISION SURGERY WAS PERFORMED. IT WAS REPORTED THAT THE L5 AND S1 SCREWS ON BOTH SIDES LOOSENED ON (B)(6) 2017. ON (B)(6) 2017: WOUND INFECTION AND LOOSENING OF THE SET SCREW L5 AND S1 LEFT AND S1 RIGHT SIDE. ON (B)(6) 2017: WOUND INFECTION AND LOOSENING OF THE SET SCREW L5 AND S1 ON BOTH SIDES. ON (B)(6) 2017: LOOSENING OF THE SET SCREW L5 AND S1 ON BOTH SIDES, REMOVAL OF THE SCREWS L5 AND S1 AND RE-INSTRUMENTATION OF L5 AND S1. THE FIRST LOOSENING OF A SET SCREW AT ALL RECOGNIZED IN A CT SCAN ON (B)(6) 2016: SCREW L5 LEFT CONSEQUENTLY THE BI-SEGMENTAL INSTRUMENTATION (L3-L5) WAS ENLARGED TO L2-S1 ON (B)(6) 2017. THEN THE POSTOPERATIVE CT SCAN SHOWED A CHANCE FRACTURE OF L 1 ABOVE THE INSTRUMENTATION WHEREUPON THE INSTRUMENTATION WAS AGAIN ENLARGED UP TO T11 ((B)(6) 2017). IN THE FURTHER COURSE THE PATIENT WAS DISCHARGED AND WAS FOLLOWED UP IN OUR OUTPATIENT CLINIC AT THE END OF (B)(6) 2017. THE L5 SCREWS WERE IMPLANTED ON (B)(6) 2016. THE S1 SCREWS WERE IMPLANTED ON (B)(6) 2017. THE SCREWS WERE REMOVED ON (B)(6) 2017.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7202958 ↗
• InjuryJan 18, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SET SCREWS LOOSENED AND DISLOCATED DUE TO WHICH A REVISION SURGERY WAS PERFORMED. IT WAS REPORTED THAT THE L5 AND S1 SCREWS ON BOTH SIDES LOOSENED ON (B)(6) 2017. ON (B)(6) 2017: WOUND INFECTION AND LOOSENING OF THE SET SCREW L5 AND S1 LEFT AND S1 RIGHT SIDE. ON (B)(6) 2017: WOUND INFECTION AND LOOSENING OF THE SET SCREW L5 AND S1 ON BOTH SIDES. ON (B)(6) 2017: LOOSENING OF THE SET SCREW L5 AND S1 ON BOTH SIDES, REMOVAL OF THE SCREWS L5 AND S1 AND RE-INSTRUMENTATION OF L5 AND S1. THE FIRST LOOSENING OF A SET SCREW AT ALL RECOGNIZED IN A CT SCAN ON (B)(6) 2016: SCREW L5 LEFT CONSEQUENTLY THE BI-SEGMENTAL INSTRUMENTATION (L3-L5) WAS ENLARGED TO L2-S1 ON (B)(6) 2017. THEN THE POSTOPERATIVE CT SCAN SHOWED A CHANCE FRACTURE OF L 1 ABOVE THE INSTRUMENTATION WHEREUPON THE INSTRUMENTATION WAS AGAIN ENLARGED UP TO T11 ((B)(6) 2017). IN THE FURTHER COURSE THE PATIENT WAS DISCHARGED AND WAS FOLLOWED UP IN OUR OUTPATIENT CLINIC AT THE END OF (B)(6) 2017. THE L5 SCREWS WERE IMPLANTED ON (B)(6) 2016. THE S1 SCREWS WERE IMPLANTED ON (B)(6) 2017. THE SCREWS WERE REMOVED ON (B)(6) 2017.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7202957 ↗
• InjuryJun 23, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SET SCREWS LOOSENED AND DISLOCATED DUE TO WHICH A REVISION SURGERY WAS PERFORMED. NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Code Available; Post Operative Wound Infection

  MAUDE report 6662702 ↗