CD HORIZON® Spinal System 25740011090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169415126), received between May 11, 2021 and Feb 25, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE SCREWS WERE COLD WELDED/STRIPPED DUE TO DRIVER MALFUNCTION INTRAOPERATIVELY. HAD TO HELICOPTER OUT AFTER NUMEROUS ATTEMPTS TO REMOVE USING A MULTITUDE OF DRIVERS. ONE OF THE DRIVER WAS SEVERELY WARPED AFTER ATTEMPTING TO PLACE 10.5 SCREW. WHEN ATTEMPTING TO PLACE SECOND SCREW (10.5X80) THE TORX TIP OF THE DRIVER SNAPPED OFF AND LODGED INSIDE THE TULIP/TORX INTERFACE OF THE SCREW. FRAGMENTS COULD NOT BE REMOVED AND IT WAS LEFT IN THE PT. THE OTHER DRIVER WAS SEVERELY WARPED AFTER ATTEMPTING TO PLACE 9.5 SCREW. SURGEON WAS FEARFUL OF SNAPPING OFF TIP OF THE DRIVER AGAIN SO THE DECISION WAS MADE TO HELICOPTER THE SCREW OUT AND LEAVE UNILATERAL PELVIC FIXATION. PRODUCTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS PSF L2-PELVIS WITH TLIF L3-5. PRE-OP DIAGNOSIS M43.16/M54.16/M40.30/M47.26. BOTH BALLAST DRIVERS WERE SEVERELY WARPED AND STRIPPED. THE PRODUCT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456265 ↗
• MalfunctionMay 11, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR PROXIMAL JUNCTIONAL KYPHOSIS. IT WAS REPORTED THAT SET SCREWS ON BOTH SIDES OF S2AI BACKED OUT AFTER THE OPERATION. BOTH WERE COMPLETELY BACKED OUT FROM THE SCREW HEAD. AT THE MOMENT, FOLLOW-UP WAS SCHEDULED, AND THE SCHEDULE FOR REOPERATION WAS UNDECIDED. THE PATIENT COULD NOT RUN OR WALK DUE TO SUDDEN NUMBNESS. X-RAY FINDINGS REVEALED THAT THE LEFT AND RIGHT S2AI SET SCREWS HAD CAME OFF. IT WAS REVISION SURGERY. IN THE INITIAL OPERATION ON (B)(6) 2017 FIXED TO T10-L4 WITH L1 VERTEBRAL COLUMN RESECTION(VCR) DUE TO L 1 FRACTURE. IN THE SECOND OPERATION ON (B)(6) 2017,EXTENSION OF FIXING DUE TO BROKEN ROD OR SOMETHING. EXTENDED TO T10-S2AI. REINFORCEMENT USING DOMINO AND COVER FOR BROKEN PART OF ROD. IN THE THIRD OPERATION ((B)(6) 2019), ONLY THE BA SET SCREW THAT WAS INSERTED INTO S2AI ON THE RIGHT CAME OFF (DISENGAGED), SO IT WAS EXPANDED WITH SURGICAL PRECISION AND THE SET SCREW WAS REPLACED. THE BREAKOFF HAD ALSO BEEN COMPLETED WITHOUT ANY PROBLEMS. IN THE FOURTH OPERATION ((B)(6) 2020).REINFORCEMENT OPERATION FOR ROD REPLACEMEN

  Patient problems: Ambulation or Postural Difficulties; Numbness

  MAUDE report 11805123 ↗
• MalfunctionMay 11, 2021Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR PROXIMAL JUNCTIONAL KYPHOSIS. IT WAS REPORTED THAT SET SCREWS ON BOTH SIDES OF S2AI BACKED OUT AFTER THE OPERATION. BOTH WERE COMPLETELY BACKED OUT FROM THE SCREW HEAD. AT THE MOMENT, FOLLOW-UP WAS SCHEDULED, AND THE SCHEDULE FOR REOPERATION WAS UNDECIDED. THE PATIENT COULD NOT RUN OR WALK DUE TO SUDDEN NUMBNESS. X-RAY FINDINGS REVEALED THAT THE LEFT AND RIGHT S2AI SET SCREWS HAD CAME OFF. IT WAS REVISION SURGERY. IN THE INITIAL OPERATION ON (B)(6) 2016, FIXED TO T10-L4 WITH L1 VERTEBRAL COLUMN RESECTION(VCR) DUE TO L 1 FRACTURE. IN THE SECOND OPERATION ON (B)(6) 2019,EXTENSION OF FIXING DUE TO BROKEN ROD OR SOMETHING. EXTENDED TO T10-S2AI. REINFORCEMENT USING DOMINO AND COVER FOR BROKEN PART OF ROD. IN THE THIRD OPERATION ((B)(6) 2019), ONLY THE BA SET SCREW THAT WAS INSERTED INTO S2AI ON THE RIGHT CAME OFF (DISENGAGED), SO IT WAS EXPANDED WITH SURGICAL PRECISION AND THE SET SCREW WAS REPLACED. THE BREAKOFF HAD ALSO BEEN COMPLETED WITHOUT ANY PROBLEMS. IN THE FOURTH OPERATION ((B)(6) 2020).REINFORCEMENT OPERATION FOR ROD REPLACEME

  Patient problems: Ambulation or Postural Difficulties; Numbness

  MAUDE report 11805115 ↗