CD HORIZON® Spinal System 5442144Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994588470), received between Aug 26, 2020 and Apr 5, 2022 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K091974); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR OLIF AND POSTERIOR OPEN SCREW PLACEMENT FOR AN INDICATION OF L2-L5 LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT DURING POSTERIOR SPINAL OPEN SURGERY SEGMENT AT L2-L5, WHEN INSTALLED THE CROSSLINK AND FIXED THE SCREW ON THE CROSSLINK, THE SCREW WAS BROKEN. AFTER REPLACED WITH THE NEW CROSSLINK, THE SCREW WAS AGAIN BROKE AND COULD NOT BE LOCKED. 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 14008974 ↗
• MalfunctionAug 26, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF LUMBAR DISC HERNIATION IN NEED OF LUMBAR DISCECTOMY USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHEN THE CROSS LINK WAS IMPLANTED, THE TAPERED PROTRUSION OF THE CROSS LINK BROKE AND FELL OFF, AND THE FIXATION OF THE CROSS LINK FAILED. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10452825 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091974. One submission often covers many models, so check the product and lot details in each record.

• Z-2876-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilizatio