CD HORIZON® Spinal System 25740019590Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169415010), received between Nov 22, 2018 and Oct 30, 2024 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT MOVED INTO TO THE INSIDE OF THE ILIAC BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564066 ↗
• InjuryApr 3, 2023Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L5/S BONE FUSION FAILURE, S2AI SET SCREW DISLODGEMENT. DATE OF INITIAL SURGERY FIRST TIME: (B)(6) 2021 , SECOND TIME: (B)(6) 2022 INITIAL SURGERY OR THE PROCEDURE TAKEN: TH4-S2AI L4/5/S PLIF (ADULT SPINAL DEFORMITY) IT WAS REPORTED THAT THE PATIENT WAS INITIALLY FIXED WITH TH4-S2AI, THEN IT WAS ONCE REPLACED WITH S2AI BY REOPERATION AND CONNECTED WITH MRC WITH DOUBLE S2AI ON BOTH SIDES AND PARALLEL ROD EXTENSION TO THE CRANIAL SIDE.  RIGHT SET SCREW CAME OFF AND REPLACEMENT RE-OPERATION WAS PERFORMED. THE INNER ROD WAS EXTENDED TO L2 AND IT WAS IN CONTACT WITH THE MRC, SO IT WAS DEPLOYED BELOW L2. WHEN ALL THE IMPLANTS WERE EXPOSED, IT WAS FOUND THAT THE TWO S2AI SET SCREWS ON THE RIGHT SIDE HAD COME OFF AS SHOWN IN THE XRAY, BUT THE SET SCREW ON THE LEFT SIDE HAD ALSO COME OFF ON THE CRANIAL SIDE. IN ADDITION, THE S2AI SCREWS ON BOTH CAUDAL SIDES HAD RODS DETACHED FROM THE HEAD ON BOTH SIDES. ON THE LEFT SIDE, THE SET SCREW WAS NOT DETACHED, BUT THE ROD WAS DETACHED FROM THE HEAD, WHICH SURPRISED THE DOCTOR. FIRST, THE PROLOCK BETWEEN L4/5 WAS REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661516 ↗
• InjuryApr 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW IN A THORACOLUMBAR POSTERIOR FIXATION FOR A FRACTURE AT S2AIS. IT WAS REPORTED THAT THE SET SCREW WAS DISLODGED. THE PATIENT COMPLAINED OF LOWER BACK PAIN AS A RESULT OF THIS EVENT. THE PATIENT NEEDED TO BE HOSPITALIZED FOR RE-SURGERY. THE SCREW WAS REPLACED WITH A NEW ONE DURING THE RE-FIXATION SURGERY. THE DATE OF IMPLANT WAS (B)(6) 2022 AND DATE OF REFIXATION WAS (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Pain

  MAUDE report 14159167 ↗
• InjuryMar 3, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION (PSF) AND POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT T10-S2AI DUE TO SPINAL KYPHOSCOLIOSIS. POST OP, SCREW LOOSENING OCCURRED AT LEFT S2AI AND DUE TO THIS RE-OPERATION HAD BEEN DONE. SCREW IN S2AI WAS REMOVED AND REPLACED WITH ILIAC SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9778806 ↗
• InjuryNov 22, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR CANAL STENOSIS AND UNDERWENT SACRAL-ILIAC FUSION AT S2 AND EXTENDING TOWARDS CAUDAL SIDE. POST-OP, THE SET SCREW OF S2AI SCREW BACKED OUT. PAIN OCCURRED DUE TO THE LOOSENING OF S1 SCREW. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO REPLACE THE SCREW.

  Patient problems: Pain

  MAUDE report 8098501 ↗