CD HORIZON® Spinal System 54840006540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994579621), received between Sep 25, 2017 and Mar 9, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT POSTERIOR LUMBAR FUSION (PLF) FOR STENOSIS. IT WAS REPORTED THAT THE SCREW WAS BROKEN. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT FIRST THREAD ON TULIP HEAD CHIPPED OFF AND NO BROKEN FRAGMENT WAS LEFT INSIDE THE PATIENT. THERE WAS NO REVISION SURGERY/ IN- PATIENT OR PROLONGATION OF EXISTING HOSPITALIZATION/ ADDITIONAL SURGERY/ DELAY IN OVERALL PROCEDURE TIME. THE IMPLANT AND EXPLANT DATE OF THE SCREW IS (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710903 ↗
• InjuryFeb 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FUSION DUE TO BACK/LEG PAIN. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED PEDICLE SCREW BROKE. HENCE, A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2020; HOWEVER, IT IS UNKNOWN IF THE SURGERY HAS BEEN PERFORMED YET OR NOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742707 ↗
• InjuryFeb 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FUSION DUE TO BACK/LEG PAIN. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED PEDICLE SCREW BROKE. HENCE, A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2020; HOWEVER, IT IS UNKNOWN IF THE SURGERY HAS BEEN PERFORMED YET OR NOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742705 ↗
• InjuryJan 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL FUSION AT L5-S1 IN 2015. POST-OP, THE SCREW BROKE. A REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN SCREWS AT S1, REFUSION AT L5-S1 AND FIXATION L4-5 ,S1-2. FRAGMENTS OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. PATIENT COMPLICATION REPORTED TO BE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8256261 ↗
• InjuryJan 9, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION. REPORTEDLY POST-OP, S1 SCREW BROKE BELOW TULIP. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF HARDWARE AND RE-INSTRUMENTATION. THE SURGEON PERFORMED AN ANTERIOR LUMBAR INTERBODY FUSION AND A REVISION POSTERIOR FUSION. NO FRAGMENTS OF THE DEVICES REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT ACHIEVE SOLID FUSION. THE PATIENT TESTED POSITIVE FOR GRAM NEGATIVE BACILLI.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7174407 ↗
• MalfunctionSep 25, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT LAMINECTOMY SURGERY AT LEVELS L5-S1. INTRA-OP, SCREW THREAD WAS DAMAGED WHEN SURGEON WAS TRYING TO FIX THE SET SCREW. THIS PROCESS WAS TRIED 3 TIMES. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6889487 ↗

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