BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONEBRIDGE

    MDR report key: 14460339 · Received May 20, 2022

    Report

    Report Number
    9710014-2022-00345
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 10, 2022
    Report Date
    September 5, 2022
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    UDI-DI
    09008738507205
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE INVESTIGATION RESULTS CONFIRMED THAT THE DEVICE HAS FAILED DUE TO AN EXTERNAL IMPACT. OTHER DAMAGES FOUND DURING INVESTIGATION ARE ATTRIBUTABLE TO THE REMOVAL SURGERY. ALL THE PROBLEMS GIVEN IN THE RECIPIENT REPORT APPEAR TO MATCH WELL WITH THIS FINDING. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED. THE USER REPORTED POOR SPEECH UNDERSTANDING WHEN USING THE DEVICE AFTER PLAYING ON THE TRAMPOLINE. THE USER WAS RE-IMPLANTED ON (B)(6) 2022.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED. THE USER REPORTED POOR SPEECH UNDERSTANDING WHEN USING THE DEVICE AFTER PLAYING ON THE TRAMPOLINE. THE USER WAS PLAYING WITH HIS BROTHER AND THEY ACCIDENTALLY RAN INTO EACH OTHER. THE USER WAS RE-IMPLANTED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186146 BONEBRIDGE BCI BONE CONDUCTION IMPLANT MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BCI601 BONE CONDUCTION IMPLANT 09008738507205

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Required Intervention