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CD Horizon® Spinal System 55740007540Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW 55740007540 5.5/6 MAS 7.5X40 CC S · Class 2 · Implant

All models of CD HORIZON Spinal System (342)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994996091), received between Apr 6, 2022 and Apr 6, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 18, 2026.

Most reported problems

Device problems

  • Loosening of Implant Not Related to Bone-Ingrowth2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 6, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A ROD AND SCREWS IMPLANTED IN A PATIENT. PROCEDURE PERFORMED IN THE INITIAL SURGERY WAS T9/S2 WAS FIXATED WITH PSF FROM DEGENERATIVE KYPHOSCOLIOSIS. PRE-OP DIAGNOSIS FOR THE REVISION SURGERY WAS BROKEN ROD, SAI SET SCREW DISLODGEMENT ON BOTH SIDES, BILATERAL S1 SCREW AND LEFT SAI SCREW LOOSENING. PROCEDURE PERFORMED IN REVISION SURGERY WAS BOTH SIDES OF S1 SCREWS AND THE LEFT SAI SCREW WERE REPLACED. IT WAS REPORTED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2021, BUT DUE TO THE BROKEN ROD, REOPERATION WAS PERFORMED ON (B)(6) 2021. A REOPERATION WAS PERFORMED BECAUSE THE ROD WAS BROKEN AGAIN, THE SET SCREW USED FOR THE SAI SCREW CAME OFF, AND THE SCREW BECAME LOOSE. THE PHYSICIAN REQUESTED THAT THE SCREW HEAD OF THE SAI SCREW THREAD BE CHECKED FOR DAMAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14024669 ↗
  • InjuryApr 6, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A ROD AND SCREWS IMPLANTED IN A PATIENT. PROCEDURE PERFORMED IN THE INITIAL SURGERY WAS T9/S2 WAS FIXATED WITH PSF FROM DEGENERATIVE KYPHOSCOLIOSIS. PRE-OP DIAGNOSIS FOR THE REVISION SURGERY WAS BROKEN ROD, SAI SET SCREW DISLODGEMENT ON BOTH SIDES, BILATERAL S1 SCREW AND LEFT SAI SCREW LOOSENING. PROCEDURE PERFORMED IN REVISION SURGERY WAS BOTH SIDES OF S1 SCREWS AND THE LEFT SAI SCREW WERE REPLACED. IT WAS REPORTED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2021, BUT DUE TO THE BROKEN ROD, REOPERATION WAS PERFORMED ON (B)(6) 2021. A REOPERATION WAS PERFORMED BECAUSE THE ROD WAS BROKEN AGAIN, THE SET SCREW USED FOR THE SAI SCREW CAME OFF, AND THE SCREW BECAME LOOSE. THE PHYSICIAN REQUESTED THAT THE SCREW HEAD OF THE SAI SCREW THREAD BE CHECKED FOR DAMAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14024456 ↗

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Sources and updates

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