BEUDAMED
    FDA Adverse Event Other Summary report: N

    PONTO IMPLANT WITH ABUTMENT

    MDR report key: 3853772 · Received May 28, 2014

    Report

    Report Number
    3007367732-2014-00017
    Event Type
    Other
    Date Received
    May 28, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 6, 2014
    Manufacturer
    OTICON MEDICAL AB
    Product Code
    MAH
    PMA / PMN Number
    K121228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INITIAL INFO (B)(4) 2014, THE COMPLAINT WAS NOT CONSIDERED MDR REPORTABLE. UPON RECEIPT OF ADD'L INFO (B)(4) 2014 THE MDR DECISION WAS REVISED. IMPLANT LOSS IS KNOWN TO OCCUR, CONSIDERED IN THE RMF AND COMMUNICATED IN THE IFU. THERE ARE NO INDICATIONS THAT THE OCCURRED IS A RESULT OF MANUFACTURING OR COMPONENT FAILURE.

    Description of Event or Problem · 1

    ACCORDING TO THE SURGEON, PATIENT PRESENTED AT OFFICE (B)(6) 2014 WITH IMPLANT LOSS. PATIENT REPORTS THAT PRIOR WEEK THE IMPLANT WAS LOOSE AND THE FOLLOWING DAY (EXACT DATE UNKNOWN), THE IMPLANT AND ABUTMENT EXTRUDED. NO PAIN OR INFECTION WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314750 PONTO IMPLANT WITH ABUTMENT BONE ANCHORED HEARING IMPLANT MAH OTICON MEDICAL AB M51137 131904

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention