BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO WIDE IMPLANT WITH ABUTMENT

    MDR report key: 2860270 · Received November 23, 2012

    Report

    Report Number
    3007367732-2012-00024
    Event Type
    Other
    Date Received
    November 23, 2012
    Date of Event
    October 31, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT BILATERAL IMPLANTS ON (B)(6) 2012. POST-OP APPOINTMENT (B)(6) 2012: WOUND SITE HEALING WELL WITH MINIMAL CRUSTING. LEFT SIDE IMPLANT LOSS ON (B)(6) 2012.

    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 M51137 113735

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention