BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1813465 · Received August 24, 2010

    Report

    Report Number
    6000034-2010-00557
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 29, 2010
    Report Date
    October 12, 2010
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN RESULTING IN HIS DECISION TO HAVE THE DEVICE EXPLANTED. THERE WAS NO REPORTED INFECTION. THE DEVICE WAS EXPLANTED ON (B)(6) 2010. THERE ARE NO PLANS TO REIMPLANT WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    ETHIBOND EXCEL GREEN BRAIDED POLYESTER SUTURE 2-0, (3.0 METRIC) 36" HAS BEEN MISTHREADED ON MULTIPLE OCCASIONS ONTO THE SH 26MM 1/2C TAPER. WHEN THE SUTURE KIT HAS BEEN STARTED IT TIGHTENS UP AND WILL NOT PULL OUT AND ANOTHER ONE HAS TO BE STARTED. I HAVE FOUR (4) IN MY POSSESSION. THEY SEEM TO BE THREADED WRONG AT THE MANUFACTURING SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention