CD HORIZON® Spinal System 5442152Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994588494), received between Oct 16, 2020 and Feb 22, 2021 — 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.

• MalfunctionFeb 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF LUMBAR DISC HERNIATION IN NEED OF POSTERIOR SPINE FIXATION, BONE GRAFTING DECOMPRESSION AND FUSION USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN AT THE CROSSLINK'S JOINT. THERE WAS A DELAY OF LESS THAN 60 MINS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11356927 ↗
• MalfunctionOct 16, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF SPINAL FRACTURE INVOLVED IN SPINAL FIXATION PROCEDURE USED IN SPINAL THERAPY. IT WAS REPORTED DURING PROCEDURE, THE INSTRUMENT BROKE AFTER IMPLANTATION, AND WAS REMOVED. THERE WAS NO FRAGMENTS LEFT IN THE PATIENT'S BODY. THERE IS NO PATIENT SYMPTOMS, OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THERE IS NO ADDITIONAL SURGERY PERFORMED. PATIENT OUTCOME: ALIVE; NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10690640 ↗

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