CD HORIZON® Spinal System 75446535Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885074134109), received between Aug 19, 2020 and Jul 30, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K042025); 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 16, 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.

• MalfunctionJul 30, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a screw used for Posterior lumbar decompression and internal fixation surgery for pre-operative diagnosis for this procedure L5-S1 intervertebral disc herniation. It was reported that the screw was broken. 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 50083541 ↗
• MalfunctionAug 24, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A POSTERIOR LUMBAR DECOMPRESSION, BONE GRAFTING, FUSION AND INTERNAL FIXATION. IT WAS REPORTED THAT THE TIP AND SHANK OF THE LEGACY UNIVERSAL SCREW WERE SEPARATED IN THE PATIENT'S BODY AFTER SURGERY. TWO SCREWS OF THIS MODEL WERE IMPLANTED AT THE SAME TIME, ONE OF WHICH WAS SEPARATED AND WAS STILL IN THE PATIENT'S BODY AND WAS NOT TAKEN OUT. THE LOT NUMBERS OF THE TWO SCREWS WERE DIFFERENT, AND IT WAS IMPOSSIBLE TO CONFIRM THE LOT NUMBER OF THE SEPARATION, SO THE TWO LOT NUMBERS WERE REPORTED AT THE SAME TIME. 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 17609374 ↗
• MalfunctionAug 24, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A P OSTERIOR LUMBAR DECOMPRESSION, BONE GRAFTING, FUSION AND INTERNAL FIXATION. IT WAS REPORTED THAT THE TIP AND SHANK OF THE LEGACY UNIVERSAL SCREW WERE SEPARATED IN THE PATIENT'S BODY AFTER SURGERY. TWO SCREWS OF THIS MODEL WERE IMPLANTED AT THE SAME TIME, ONE OF WHICH WAS SEPARATED AND WAS STILL IN THE PATIENT'S BODY AND WAS NOT TAKEN OUT. THE LOT NUMBERS OF THE TWO SCREWS WERE DIFFERENT, AND IT WAS IMPOSSIBLE TO CONFIRM THE LOT NUMBER OF THE SEPARATION, SO THE TWO LOT NUMBERS WERE REPORTED AT THE SAME TIME. 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 17609369 ↗
• InjurySep 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREWS IN AN UNKNOWN SPINAL THERAPY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE SCREWS BROKE INSIDE THE PATIENT. THE PATIENT WAS OPERATED ON (B)(6) 2021 AND 4 SCREWS WERE PLACED. AT THE CONTROL APPOINTMENT ON (B)(6) 2021, THE HCP DETECTED THAT 2 OF THE SCREWS BROKE THREE MONTHS LATER. THERE WAS NO PATIENT INJURY. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE SCREW WILL BE REPLACED WITH SURGICAL INTERVENTION. THE DATE OF IMPLANT (B)(6) 2021. THE REPLACEMENT WAS MADE ON (B)(6) 2021. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511542 ↗
• MalfunctionAug 19, 2020Device Damaged by Another Device; Device Damaged by Another Device

  INFORMATION RECEIVED FROM INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING AN INTRA-OP FOR A P RE-OPERATIVE DIAGNOSIS OF LUMBAR DEGENERATIVE DISEASE. IT WAS REPORTED THAT DURING THE SCREW IMPLANTATION PROCESS, THE TIP OF THE SCREWDRIVER WAS BROKEN IN THE SCREW. AFTER THE SCREW WAS REMOVED, A NEW SCREW WAS IMPLANTED AND THE OPERATION CONTINUED. THE STATUS OF THE SCREW REMAINED AS EXPLANTED-COMPLETE. THERE WERE NO PATIENT SYMPTOMS WERE REPORTED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS TO PATIENT/PHYSICIAN WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON 31-JUL-2020: THE DAMAGED SCREW WAS REPLACED WITH NEW SCREW IN THE SAME SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10424063 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042025. One submission often covers many models, so check the product and lot details in each record.

• Z-0464-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800
• Z-0465-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Py
• Z-2878-2011 · Jun 28, 2011 · Terminated
  ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilizat
• Z-2875-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization a