BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO WIDE IMPLANT 3MM

    MDR report key: 3200088 · Received June 20, 2013

    Report

    Report Number
    3007367732-2013-00015
    Event Type
    Other
    Date Received
    June 20, 2013
    Date of Event
    April 3, 2013
    Report Date
    June 20, 2013
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    LXB
    PMA / PMN Number
    K112053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT LOSS IS KNOWN TO OCCUR, CONSIDERED IN THE RMF AND COMMUNICATED IN THE PATIENT INFORMATION. THERE ARE NO INDICATIONS THAT THE OCCURRED IS A RESULT OF MANUFACTURING OR COMPONENT FAILURE.

    Description of Event or Problem · 1

    WHILE JUMPING ON TRAMPOLINE, PATIENT HIT THE METAL RAILING ON SIDE OF IMPLANT. PATIENT EXPERIENCED PAIN AND NOTICED THE ABUTMENT FELT LOOSE. CALLED PHYSICIAN'S OFFICE AND WAS SEEN ON (B)(6) 2013. AT THAT TIME, IT WAS REPORTED THE IMPLANT/ ABUTMENT HAD COME OUT. PATIENT TO BE REIMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280981 PONTO WIDE IMPLANT 3MM BONE ANCHORED HEARING IMPLANT LXB OTICON MEDICAL AB M51142 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention