CD HORIZON® Spinal System 54840007535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994589316), received between May 25, 2022 and Feb 15, 2023 — classified as 2 injuries.

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.

• InjuryFeb 15, 2023Break; Break

  INFORMATION WAS RECEIVED FROM CONSUMER VIA MANUFACTURER REPRESENTATIVE THAT THE BROKEN SCREWS WERE AT THE BOTTOM. THE BROKEN SCREWS WERE EXPLANTED AND IN THE POSSESSION OF PATIENT. THE PROCEDURE/TECHNIQUE PERFORMED DURING REVISION WAS DECOMPRESSIVE LUMBAR LAMINECTOMY L3-S1, REMOVAL OF HARDWARE, EXPLORATION OF FUSION, NEUROLYSIS, FUSION, ILIAC CREST MARROW ASPIRATION, ALLOGRAFT, AUTOGRAFT WITH INSTRUMENTATION, BONE MORPHOGENETIC PROTEIN. (B)(6) 2021: PATIENT HAD S/P LUMBAR FUSION L3-S1 PERFORMED IN (B)(6) 2020. PATIENT WAS DOING VERY WELL POST-OPERATIVELY UNTIL SEVERAL WEEKS AGO. SHE DEVELOPED ACUTE PAIN IN HER RIGHT BUTTOCK AND RIGHT HIP WITH RADIATION INTO THE RIGHT LOWER EXTREMITY. SHE STATES THIS DID NOT GIVE HER ANY PAIN RELIEF. PATIENT DENIES ANY BOWEL OR BLADDER CHANGES OR SADDLE ANESTHESIA. RADIOGRAPHS: PLAIN FILMS AP LATERAL OF THE LUMBAR SPINE ARE PERFORMED TO EVALUATE THE FUSION DEMONSTRATE INSTRUMENTED FUSION L3-S1. THIS WAS NOT SEEN ON PREVIOUS X-RAYS. PATIENT DENIES ANY FALLS OR TRAUMAS. IMPRESSION: S/P LUMBAR FUSION, LUMBAR DDD WITH RADICULAR SYMPTOMS. (B)(6) 2021: PATIENT RETURNED FOR RE-EVALUATION. PATIENT HAD S/P DECOMPRESSION AND FUSION WITH INSTRUMENTATION L3-S1.

  Patient problems: Numbness

  MAUDE report 16377525 ↗
• InjuryMay 25, 2022Break; Break

  INFORMATION WAS RECEIVED FROM CONSUMER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED SCREW IMPLANTED DURING INITIAL SURGERY. IT WAS REPORTED THAT, THE SCREWS WERE BROKEN. PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2020 WITH REPORTED SCREW AND HAS TO RECEIVE REVISION SURGERY ON  (B)(6) 2021 DUE TO BREAKAGE OF SCREWS. PATIENT REPORTED THAT SHE HAS NUMBNESS IN RIGHT LEG. THE BROKEN SCREWS WERE AT THE BOTTOM. THE BROKEN SCREWS WERE EXPLANTED AND IN THE POSSESSION OF PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Numbness

  MAUDE report 14495070 ↗

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