CD HORIZON® Spinal System 1604200500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994990693), received between Jun 2, 2017 and Nov 18, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FUSION SPINAL T HERAPY. IT WAS REPORTED THAT THE TULIP FROM THE MAS-SCREW HAD COME LOOSE FROM THE SCREW AND THE RODS IN THE CONSTRUCTION WERE BROKEN. THE BROKEN TULIP WAS ON LEFT L4 AND THE ROD ON THE LEFT SIDE WAS BROKEN ON TWO SPOTS WHILE THE ROD ON THE RIGHT SIDE WAS BROKEN IN ONE POSITION. THERE WAS PAIN IN THE AREA OF THE BACK WHERE THE BROKEN SCREW WAS LOCATED NEAR L4. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE ROD BELONGS TO MDT.

  Patient problems: Pain

  MAUDE report 23584762 ↗
• InjuryNov 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FUSION SPINAL T HERAPY. IT WAS REPORTED THAT THE TULIP FROM THE MAS-SCREW HAD COME LOOSE FROM THE SCREW AND THE RODS IN THE CONSTRUCTION WERE BROKEN. THE BROKEN TULIP WAS ON LEFT L4 THERE WAS PAIN IN THE AREA OF THE BACK WHERE THE BROKEN SCREW WAS LOCATED NEAR L4. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE ROD BELONGS TO MDT.

  Patient problems: Pain

  MAUDE report 23584265 ↗
• InjuryAug 21, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING HARDWARE REMOVA L/REVISION. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS NON-UNION DUE TO HARDWARE ISSUES. IT WAS REPORTED THAT WHEN THE DRIVER WAS USED TO REMOVE A SOLERA SCREW, THE TIP OF THE DRIVER WAS BROKEN. THE BROKEN TIP WAS RETRIEVED.  THE PATIENT/PROCEDURE WAS NOT IMPACTED IN ANY WAY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 20020330 ↗
• InjuryJun 2, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH ADULT DEGENERATIVE DISEASE AND SCOLIOSIS UNDERWENT SPINAL SURGERY FROM T10 - PELVIS. POST-OP ROD BREAKAGE AT L5-S1 WAS OBSERVED CAUSING PAIN TO THE PATIENT. IT IS NOT CONFIRMED WHETHER SURGEON WILL PERFORM REVISION SURGERY ON THE PATIENT.

  Patient problems: Pain

  MAUDE report 6607197 ↗

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.