BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

    MDR report key: 20123547 · Received September 3, 2024

    Report

    Report Number
    1030489-2024-01079
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 3, 2024
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANT DATE IS UNKNOWN G4: PLEASE NOTE THAT 75476540 IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE WITH PORODUCT ID - 55840021540T, UDI - (B)(4) AND 510(K) - K152604.¿ MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING EXTENSION OF EX ISTING CONSTRUCT AND DECOMPRESSION. IT WAS REPORTED THAT TULIP HEAD SHEARED FROM SCREW, IT WAS REMOVED DURING REVISION EXTENSION PROCEDURE. SCREW SHANK IS WITHIN VERTEBRAL BONE, ONLY PROTRUDING SECTION OF SCREW BROKE AND DETACHED. EXTENSION OF EXISTING CONSTRUCT WAS ALREADY PLANNED, BROKEN SCREW DISCOVERED INTRA-OP AND REVISION WAS NOT DUE TO SCREW MALFUNCTION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369573 CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 75476540 H5413769

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown