BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3185943 · Received June 24, 2013

    Report

    Report Number
    6000034-2013-01122
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    May 21, 2013
    Report Date
    October 22, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNAVAILABLE FOR ANALYSIS. CORRECTION: THE CORRECT PATIENT IDENTIFIER IS (B)(6). CORRECTION: THE CORRECT PMA NUMBER IS K984162; NOT K955713 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED MAY 19, 2014.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2013, RESULTING IN FIXTURE LOSS. THERE ARE PLANS TO ACCESS THE SLEEPER FIXTURE AND IMPLANT A NEW SLEEPER FIXTURE, HOWEVER, IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286536 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention