BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO WIDE IMPLANT WITH ABUTMENT

    MDR report key: 2860267 · Received November 23, 2012

    Report

    Report Number
    3007367732-2012-00021
    Event Type
    Other
    Date Received
    November 23, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 23, 2012
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    LXB
    PMA / PMN Number
    K112053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED PAIN AT IMPLANT SITE ON (B)(6) 2012. ON (B)(6) 2012 PATIENT NOTICED IMPLANT FELT LOOSE AND IMPLANT CAME OUT OF IMPLANT SITE. PATIENT GIVEN KEFLEX AND ELOCON CREAM AND WAS SEEN BY SURGEON ON (B)(6) 2012 WHERE IT WAS CONFIRMED IMPLANT LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PONTO WIDE IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT LXB OTICON MEDICAL AB M51139 113826

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention| S ELOCON CREAM| KEFLEX