BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO WIDE IMPLANT WITH ABUTMENT

    MDR report key: 2860268 · Received November 23, 2012

    Report

    Report Number
    3007367732-2012-00022
    Event Type
    Other
    Date Received
    November 23, 2012
    Date of Event
    August 29, 2012
    Report Date
    November 23, 2012
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    MAH
    PMA / PMN Number
    K112053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A IMPLANT SITE INFECTION. INFECTION WAS BEING TREATED AND FOR UNK REASON IMPLANT CAME OUT. ACCORDING TO THE PT THERE WAS NO TRAUMA INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PONTO WIDE IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT MAH OTICON MEDICAL AB M51136 113550

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention