BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4232939 · Received November 6, 2014

    Report

    Report Number
    6000034-2014-01632
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    December 18, 2013
    Report Date
    November 7, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT PATIENT IDENTIFIER IS (B)(6); NOT 713626 AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT CATALOG NUMBER IS 93329; NOT 93331 AS PREVIOUSLY REPORTED. THIS REPORT FILED NOVEMBER 10, 2014. THE IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. ON (B)(6) 2014 THE PATIENT UNDERWENT A PROCEDURE FOR SITE DEBRIDEMENT AND WAS PRESCRIBED ORAL ANTIBIOTICS. SUBSEQUENTLY, THE PATIENT DEVELOPED AN INFECTION AND THE GRANULATION TISSUE WAS CAUTERIZED WITH SILVER NITRATE (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713268 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention