BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4765804 · Received May 12, 2015

    Report

    Report Number
    6000034-2015-00840
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    April 13, 2011
    Report Date
    July 29, 2015
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PATIENT IDENTIFIER IS (B)(6); NOT (B)(6) AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT PMA NUMBER IS K984162; NOT K955713 AS PREVIOUSLY REPORTED. THIS REPORT FILED ON OCTOBER 9, 2015.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED WOUND DEHISCENCE AT THE IMPLANT SITE. SUBSEQUENTLY ON (B)(6) 2011 THE PATIENT UNDERWENT REVISION SURGERY FOR WOUND DEBRIDEMENT. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308739 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention