BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3030279 · Received March 28, 2013

    Report

    Report Number
    3004230826-2013-00030
    Event Type
    Injury
    Date Received
    March 28, 2013
    Report Date
    March 22, 2013
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO INNSBRUCK WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2013, TO REPOSITION THE DEVICE. DURING THE REVISION SURGERY IT WAS SEEN THAT THE DEVICE CONDUCTOR LINK HAD STRONGLY GROWN INTO THE BONE. ON TRYING TO EXPOSE THE FMT, THE CONDUCTOR LINK WAS ACCIDENTALLY CUT. THE PATIENT WAS RE-IMPLANTED IN THE SAME SURGERY WITH A BONEBRIDGE. THE FMT WAS LEFT IN THE PATIENT DUE TO STRONG OSSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127535 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention