BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3894243 · Received June 25, 2014

    Report

    Report Number
    6000034-2014-00882
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE RESULTING IN LOSS OF OSSEOINTEGRATION ON (B)(6), 2014. ON (B)(6), 2014, THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369997 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention