BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4070594 · Received September 8, 2014

    Report

    Report Number
    6000034-2014-01299
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    August 12, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED ON SEPTEMBER 4, 2014, AND NO PRODUCT FAULT NOR PROCESS DEVIATION WAS FOUND. THIS REPORT IS FILED, SEPTEMBER 9, 2014.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS HOSPITALISED FOR 5 DAYS (SPECIFIC DATES NOT REPORTED) DUE TO PAIN SUBSEQUENT TO UNDERGOING INITIAL IMPLANTATION ON (B)(6) 2014. THE FIXTURE WAS NOT IMPLANTED DUE TO POOR BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547979 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93331 151581

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R