CD HORIZON® Spinal System 5442147Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994588487), received between Oct 16, 2017 and Mar 31, 2021 — classified as 1 injury, 6 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2021Break; Material Deformation; Break; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT THE CAP WAS BROKEN. THERE WAS A DELAY OF MORE THAN 60 MINS REPORTED IN OVERALL PROCEDURE TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594006 ↗
• MalfunctionFeb 3, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT SPINAL THERAPY FOR SPINAL FRACTURE. IT WAS REPORTED THAT THE CROSSLINK WAS BROKEN DURING PROCEDURE. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021: THE CONICAL PROTRUSION OF THE CROSSLINK SCREW PLUG (THE CLAMPING ROD) WAS BROKEN AND FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11270850 ↗
• MalfunctionJul 1, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THORACOLUMBAR/LUMBAR SPINE SURGERY DUE TO BURST FRACTURE OF THE LUMBAR 4 VERTEBRAL BODY. INTRA-OP, WHILE USING CROSSLINK FOR BREAKING SCREW PLUG, THE LOWER SIDE OF ONE SIDE OF THE SCREW PLUG BROKE AT THE THREADED JOINT. IT WAS REMOVED INTRA-OPERATIVELY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

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

  MAUDE report 10216723 ↗
• MalfunctionDec 27, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INSTRUMENTATION AND FUSION AT L4-S1 DUE TO SPINAL DEGENERATION. INTRA-OP, CENTRE BLUE NUT OF THE CROSSLINK STRIPPED AND WOULD NOT CLICK. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9522841 ↗
• MalfunctionDec 15, 2017Break; Break

  PRE-OP DIAGNOSIS: SPINAL STENOSIS PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION(PLIF) LEVELS IMPLANTED: "1" LEVEL IT WAS REPORTED THAT DURING SURGERY, THE SCREW BROKE AND SHEARED OFF WHEN THE SURGEON WAS TORQUING IT DOWN. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7120368 ↗
• MalfunctionDec 15, 2017Break; Break

  PRE-OP DIAGNOSIS: SPINAL STENOSIS PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION(PLIF) LEVELS IMPLANTED: "1" LEVEL IT WAS REPORTED THAT DURING SURGERY, THE SCREW BROKE AND SHEARED OFF WHEN THE SURGEON WAS TORQUING IT DOWN. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7120366 ↗
• MalfunctionOct 16, 2017Material Deformation; Material Deformation

  TYPE OF PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) IT WAS REPORTED THAT INTRA-OP, MIDDLE NUT OF CROSSLINK WAS STRIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6950773 ↗

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