CD HORIZON® Spinal System 55840009590Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169005327), received between Apr 26, 2019 and Jan 17, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionJan 17, 2020Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DECOMPRESSION AND FUSION AT L3-PELVIS. THIS WAS A REVISION TO A PRIOR SURGERY. INTRA-OP, THE SCREW HEAD BECAME LOCKED. THE HEAD COULD NOT MOVE MULTI-AXIALLY; AND COULD NOT CONNECT TO THE CONSTRUCT. HENCE, THE SCREW WAS REMOVED AND WAS REPLACED WITH A NEW ONE. REPORTEDLY, THE ALLEGED SCREW BROKE AS WELL, BUT NO BROKEN FRAGMENTS REMAINED INSIDE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9603745 ↗
• MalfunctionJan 17, 2020Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DECOMPRESSION AND FUSION AT L3-PELVIS. THIS WAS A REVISION TO A PRIOR SURGERY. INTRA-OP, THE SCREW HEAD BECAME LOCKED. THE HEAD COULD NOT MOVE MULTI-AXIALLY; AND COULD NOT CONNECT TO THE CONSTRUCT. HENCE, THE SCREW WAS REMOVED AND WAS REPLACED WITH A NEW ONE. REPORTEDLY, THE ALLEGED SCREW BROKE AS WELL, BUT NO BROKEN FRAGMENTS REMAINED INSIDE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9603742 ↗
• MalfunctionApr 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION (PSF) FORM T10 TO S2 DUE TO DEGENERATIVE SCOLIOSIS. POST-OP, THE IMPLANTED SCREW WAS BROKEN AND BROKEN PARTS ARE STILL IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT. PATIENT DID NOT UNDERGO ANY REMOVAL SURGERY YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554214 ↗

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.