CD HORIZON® Spinal System 55410005540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169074538), received between Mar 20, 2020 and Apr 23, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K113174); they may or may not involve this specific model.

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.

• InjuryApr 23, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED IN SCOLIOSIS. IT WAS REPORTED THAT THE SCREWS WERE BROKEN. THE SCREWS WERE EXPLANTED. THERE WAS NO PATIENT SYMPTOMS IN THE EVENT AND NO FURTHER COMPLICATIONS/SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT UNDERWENT T8 TO L3 SPINAL FUSION ON (B)(6) 2022. ACCORDING TO THE SURGEON THE PATIENT REPORTED PAIN WHICH TRIGGERED THE NEED FOR A SCAN WHICH LED TO THE DISCOVERY OF BROKEN SCREWS. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. FROM (B)(6) 2023 _E1 (HCP, REP, FOR): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER RE PRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN AN UNKNOWN SPINAL THERAPY. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT HAD CORRECTIVE SURGERY, APPROXIMATELY 8 MONTHS AGO. SURGEON HAD USED MONO-AXIAL AND POLY-AXIAL SCREWS IN CORRECTING THE DEFORMITY. THE PATIENT WAS THEN BROUGHT BACK TO HAVE THE BROKEN SCREWS REMOVED. UPON REMOVAL OF THE SCREWS, IT WAS NOTED THAT FOUR OF THE MONO-AXIAL SCREWS WERE BROKEN IN L3 AND L4 HALF

  Patient problems: Pain

  MAUDE report 16792988 ↗
• MalfunctionMar 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TREATMENT OF SCOLIOSIS. INTRA-OP, THE FIXED ANGLE SCREW WARPED AFTER THE REDUCTION. HENCE, THE SCREW WAS EXPLANTED; AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9862173 ↗
• MalfunctionMar 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TREATMENT OF SCOLIOSIS. INTRA-OP, THE FIXED ANGLE SCREW WARPED AFTER THE REDUCTION. HENCE, THE SCREW WAS EXPLANTED; AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9861887 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2018 · Jul 9, 2018 · Terminated
  Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.