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CD HORIZON® Spinal System 7226540Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CDH LEGACY PEEK 7226540 MAS 6.5X40 · Class 2 · Implant

All models of CD HORIZON Spinal System (342)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074362892), received between Feb 7, 2017 and Sep 11, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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

Device problems

  • Break3

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Code Available1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 11, 2019Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT L4-S1 FUSION AND STABILIZATION. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW BROKE. BROKEN SCREWS AND RODS WERE OBSERVED ON PATIENT'S X-RAY. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BROKEN IMPLANTS WERE EXPLANTED AND WERE REPLACED BY IMPLANTS FROM ANOTHER MANUFACTURER. NO FRAGMENT OF THE BROKEN IMPLANTS REMAINED INSIDE THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8987632 ↗
  • InjurySep 11, 2019Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT L4-S1 FUSION AND STABILIZATION. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW BROKE. BROKEN SCREWS AND RODS WERE OBSERVED ON PATIENT'S X-RAY. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BROKEN IMPLANTS WERE EXPLANTED AND WERE REPLACED BY IMPLANTS FROM ANOTHER MANUFACTURER. NO FRAGMENT OF THE BROKEN IMPLANTS REMAINED INSIDE THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8987520 ↗
  • InjuryFeb 7, 2017Break; Break

    PROCEDURE: MINIMALLY INVASIVE INTERSOMATIC ARTHRODESIS LEVELS OF IMPLANT: L5-S1 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP,THE RIGHT SACRAL SCREW OF S1 BROKE INSIDE THE PATIENT AND THE DISTAL PART OF THIS SCREW REMAINS IN THE PATIENT. A REVISION SURGERY WAS PERFORMED AND THE PROXIMAL PART OF THE SCREW WAS EXPLANTED. PATIENT COMPLICATIONS AS A RESULT OF THIS REVISION SURGERY HAVE BEEN REPORTED AS UNKNOWN.

    Patient problems: No Code Available

    MAUDE report 6306437 ↗

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Sources and updates

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