BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1173451 · Received September 23, 2008

    Report

    Report Number
    6000034-2008-00554
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    July 1, 2007
    Report Date
    September 4, 2008
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS, AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT REPORTED THAT THE ABUTMENT FELL OFF IN 2007 (ESTIMATED), BUT SHE DID NOT SEEK MEDICAL ATTENTION. THE PT HAD UNDERGONE A TISSUE REDUCTION SURGERY PRIOR TO THE ABUTMENT FALLING OFF (DATE NOT REPORTED). SINCE THEN, THE SKIN HAS GROWN OVER THE FLANGE FIXTURE. MEDICAL EVALUATION OF THE SURGICAL SITE WAS RECOMMENDED. NO FURTHER INFO WAS REPORTED AT THE TIME OF THIS REPORT, FILED SEPT 23, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT LXB COCHLEAR BONE ANCHORED SOLUTIONS, AB 90305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention