CD HORIZON® Spinal System 54840017545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994593351), received between May 25, 2018 and May 23, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjuryMay 23, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING A DEVICE. IT WAS REPORTED THAT ANTEROPOSTERIOR AND LATERAL X-RAY TAKING LUMBAR FUSION PROVIDED. AN INTERESTING CONSTRUCT WITH AN OBLIQUE ARCUTATION OF THE BILATERAL RODS ARE PRESENT. THERE AT LEAST ONE PARTIAL SCREW SHRINK CONTAINED IN THE SUPERVALU VERTEBRAL BODY CONSISTENT WITH THE PROVIDED HISTORY OF FRACTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10084477 ↗
• InjuryFeb 1, 2020Fracture; Fracture

  IT WAS REPORTED VIA PATIENT CALL THAT ON AN UNKNOWN DATE IN (B)(6) 2018, THE PATIENT UNDERWENT A BACK SURGERY USING RODS AND SCREWS. REPORTEDLY, IT WAS HER 6TH SURGERY. ON AN UNKNOWN DATE, POST-OP, PATIENT SUFFERED WITH PAIN. ALLEGEDLY, THE SCREW, IMPLANTED AT S1, FRACTURED AT ITS MID-SHAFT. HENCE, THE PATIENT HAD TO UNDERGO ANOTHER SURGERY IN (B)(6) 2019. ACCORDING TO THE REPORTED INFORMATION, THE PATIENT IS STILL SUFFERING FROM PAIN.

  Patient problems: Pain

  MAUDE report 9656792 ↗
• InjuryMay 25, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) AT L5-S1 DUE TO LUMBAR DEGENERATIVE DISEASE. POST-OPERATIVELY, SCREW BROKE AND PAIN WAS OBSERVED. AS A RESULT, A REVISION SURGERY WAS PERFORMED AND BROKEN LEFT S1 SCREW WAS EXPLANTED. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 7543903 ↗

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