BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3041604 · Received April 8, 2013

    Report

    Report Number
    6000034-2013-00620
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    April 24, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, ON (B)(6) 2011, THE PATIENT UNDERWENT A PROCEDURE FOR DEBRIDEMENT OF THE IMPLANT SITE SUBSEQUENT TO SUSTAINING TRAUMA TO THE SITE APPROXIMATELY ONCE WEEK PRIOR. THE PATIENT WAS ALSO TREATED WITH ORAL ANTIBIOTICS (TYPE AND AMOUNT NOT REPORTED). ON (B)(6) 2012, THE PATIENT UNDERWENT THE SECOND PROCEDURE FOR DEBRIDEMENT OF SITE DUE TO SKIN OVERGROWTH. ON (B)(6) 2013, THE PATIENT UNDERWENT A THIRD PROCEDURE FOR DEBRIDEMENT OF SITE AND ABUTMENT EXCHANGE. THE IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN OVERGROWTH OF SKIN TISSUE AROUND THE IMPLANT SITE. THE PATIENT UNDERWENT SEVERAL DEBRIDEMENT PROCEDURES (DATES NOT REPORTED), AND THE ABUTMENT WAS ALSO EXCHANGED ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT PROVIDED AS OF THE DATE OF THIS REPORT, (B)(4) 2013. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143550 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention