CD Horizon® Spinal System 5530030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169210158), received between May 10, 2021 and Oct 31, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR THE PSEUDOARTHROSIS AT L5-S1. IT WAS REPORTED THAT THE SET SCREW LOST DEBRIS IN THE WOUND, WHICH WAS REMOVED DURING THE REVISION PROCEDURE. THE PATIENT EXPERIENCED BROKEN RODS AND PSEUDOARTHROSIS SPECIFICALLY AT THE L5-S1 LEVEL. THE REVISION INVOLVED THE USE OF DOUBLE RODS AND REPLACEMENT OF SET SCREWS. RADIOGRAPHIC IMAGES AND MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. THE RODS WERE BROKEN DUE TO PSEUDOARTHROSIS, AND NEW RODS AND SET SCREWS WERE IMPLANTED. THE IMPLANTS WERE REMOVED AND REPLACED, WITH NO FRAGMENTS REMAINING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434453 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED TRANSFORAMINAL LUMBAR INTERBODY FUSION THERAPY FOR THE DISC HERNIATION. LEVELS IMPLANTED WERE L1/2. REASON FOR REPEAT SURGERY WAS RESTENOSIS AFTER DISC HERNIATION. IT WAS REPORTED THAT THE IMPLANT HAD RUN OUT OF STERILIZATION DURING THE INVESTIGATION.THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE IS NO DETAILED MALFUNCTION/ALLEGATION REGARDING THE SET SCREW. THE PARALYSIS DID NOT IMPROVE, SO ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025; AT THAT TIME, ALL SET SCREWS WERE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PARALYSIS WAS NOT CAUSED BY THE SET SCREW, SO IT HAS NOTHING TO DO WITH IT.

  Patient problems: Paralysis

  MAUDE report 21352599 ↗
• MalfunctionSep 19, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING EXTENSION OF THE EXISTING SPONDYLODESIS WITH S2 ALA ILEUM SCREWS AND CONNECTORS FOR A DOUBLE-ROD TECHNIQUE IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO BREAK OFF THE LOCKING SCREW, IT DIDN'T WORK. THE SCREW COULDN'T BE BROKEN OFF. THE SURGEON TRIED WITH 2 LOCKING SCREWS AND NEITHER COULD BE BROKEN OFF. THERE WAS METAL ABRASION BETWEEN THE THREAD OF THE CONNECTOR AND THE LOCKING SCREW, SO THAT NO SCREW COULD HOLD THEN. THEREFORE, THE CONNECTOR HAD TO BE REPLACED AND THE OPERATION TOOK LONGER. THERE WAS 60 MINS OF PROCEDURAL DELAY.  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 20258495 ↗
• InjuryOct 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD REOPERATION. IT WAS REPORTED THAT PATIENT HAD REOPERATION DUE TO SCREW DISLODGEMENT. THE INITIAL SURGERY WAS L1-PELVIC. PREOPERATIVE DIAGNOSIS WAS TRAUMA. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903519 ↗
• MalfunctionSep 27, 2023Product Quality Problem; Product Quality Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT WHEN INSERTING THE SET SCREW, THE COATING OF THE SET SCREW LET LOOSE IN THE SCREW AND SET SCREW WOULD NOT FIXATE. THE THREADING OF THE SET SCREW SEEMED DAMAGED AND THE COATING LET GO OF THE SET SCREW ITSELF. THIS REVISION SURGERY WAS PERFORMED AS PATIENT EXPERIENCED PAIN AFTER FIRST SURGERY DUE TO THE LENGTH OF THE CONSTRUCT. GOAL OF SURGERY WAS TO SHORTEN THE CONSTRUCT AND INCREASE THE MOBILITY OF THE PATIENT. THERE WERE NO PRODUCT ALLEGATION/MALFUNCTION ASSOCIATED WITH ANY OF THE MDT PRODUCTS THAT WERE USED IN INITIAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823533 ↗
• MalfunctionSep 27, 2023Product Quality Problem; Product Quality Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT WHEN INSERTING THE SET SCREW, THE COATING OF THE SET SCREW LET LOOSE IN THE SCREW AND SET SCREW WOULD NOT FIXATE. THE THREADING OF THE SET SCREW SEEMED DAMAGED AND THE COATING LET GO OF THE SET SCREW ITSELF. THIS REVISION SURGERY WAS PERFORMED AS PATIENT EXPERIENCED PAIN AFTER FIRST SURGERY DUE TO THE LENGTH OF THE CONSTRUCT. GOAL OF SURGERY WAS TO SHORTEN THE CONSTRUCT AND INCREASE THE MOBILITY OF THE PATIENT. THERE WERE NO PRODUCT ALLEGATION/MALFUNCTION ASSOCIATED WITH ANY OF THE MDT PRODUCTS THAT WERE USED IN INITIAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823503 ↗
• InjuryMay 6, 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 SPINAL PRODUCTS IN A THORACOLUMBAR POSTERIOR FIXATION FOR A FRACTURE AT S2AIS. IT WAS REPORTED THAT THE SECOND SET SCREW WAS DISLODGED. NO FAILURES WERE REPORTED FOR THE OTHER SET SCREWS AND RODS OTHER THAN THE 2ND BACKED OUT SET SCREW. 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 ROD WAS REMOVED TO REPLACE THE SCREW IN THE REVISION SURGERY. THE SCREW WAS REPLACED AND FIXED WITH A NEW ROD AND NEW SET SCREW BECAUSE THE SCREW HEAD MAY HAVE BEEN DAMAGED.. THE PRODUCTS WERE FIXED NORMALLY AND NO ABNORMALITIES WERE REPORTED. THE DATES 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 14301828 ↗
• InjuryMay 10, 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) 2019 , 2016, FIXED TO T10-L4 WITH L1 VERTEBRAL COLUMN RESECTION(VCR) DUE TO L 1 FRACTURE. IN THE SECOND OPERATION ON (B)(6) 2019 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796722 ↗
• InjuryMay 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPDATED INFORMATION RECEIVED ON 19-OCT-2021: THE INITIAL OPERATION ((B)(6), 2016). FIXATION AT T10-L4 FOR L1VCR. SECOND OPERATION ((B)(6), 2019). EXTENSION OF FIXATION DUE TO ROD BREAKAGE OR SOMETHING. EXTENSION TO T10 -S2AI. REINFORCEMENT AND COVER OF ROD BROKEN PART USING DOMINO. THIRD OPERATION ((B)(6), 2020). ONLY THE BA SET SCREW THAT WAS INSERTED INTO THE S2AI ON THE RIGHT CAME OFF (DISENGAGED), SO PINPOINT OPEN WAS PERFORMED AND THE SET SCREW WAS REPLACED. THE BREAKOFF HAD ALSO BEEN COMPLETED WITHOUT ANY PROBLEMS. FOURTH OPERATION ((B)(6), 2021). PJK DEVELOPED, THE ROD SHOULD HAVE BEEN BROKEN, THE ROD WAS REPLACED, AND REINFORCEMENT OPERATION SUCH AS FUSION EXTENSION TO T7 WAS PERFORMED. THE S2AI SCREW WAS ALSO REPLACED AND VARIOUS SET SCREWS WERE ALSO REPLACED WITH NEW ONES. FIFTH OPERATION ((B)(6), 2021). NUMBNESS OCCURRED SUDDENLY AND THE PATIENT BECAME UNABLE TO RUN AND WALK. X-RAY FINDINGS REVEALED THAT THE LEFT AND RIGHT S2AI SET SCREWS HAD COME OFF (DISENGAGED). EXTENSION WAS PERFORMED TO T3 DUE TO THE PJK ABOVE. THEY WERE CONFIRMING THAT THE SET SCREWS WERE REPLACED. SIXTH OPERATION ((B)(6), 2021). SET SCREWS ON BOTH SIDES OF S2 BACKED OUT. THE PRODUCTS WERE REPLACED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796700 ↗