BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP MAGNET 3

    MDR report key: 5945277 · Received September 13, 2016

    Report

    Report Number
    6000034-2016-01771
    Event Type
    Injury
    Date Received
    September 13, 2016
    Report Date
    October 18, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FILED SEPTEMBER 13, 2016. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CORRECT BRAND NAME IS, SP MAGNET 3; NOT FLANGE FIXTURE AND ABUTMENT AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS, COCHLEAR BAHA ATTRACT SYSTEM; NOT LXB AS PREVIOUSLY REPORTED. THE CORRECT MODEL # IS, 95773; NOT BI300 AS PREVIOUSLY REPORTED. THE CORRECT CATALOG # IS, 95773; NOT 92129 AS PREVIOUSLY REPORTED. THE CORRECT LOT # IS, 104351; NOT 174781 AS PREVIOUSLY REPORTED. THE CORRECT PMA/510(K) IS, K131240; NOT K100360 AS PREVIOUSLY REPORTED. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AT THE IMPLANT MAGNET SITE. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596972 SP MAGNET 3 COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 95773 104351

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention