BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR BAHA ATTACT SYSTEM

    MDR report key: 5867404 · Received August 10, 2016

    Report

    Report Number
    6000034-2016-01521
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    June 17, 2016
    Report Date
    August 16, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED). THIS REPORT IS FILED (B)(6) 2016. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016, TO REMOVE THE INTERNAL MAGNET AND REPLACE WITH AN ABUTMENT. (B)(6).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE BRAND PRODUCT NAME IS COCHLEAR BAHA ATTACT SYSTEM, NOT FLANGE FIXTURE AND ABUTMENT, AS PREVIOUSLY REPORTED. CORRECTION: THE COMMON DEVICE NAME AND PRODUCT CODE IS LXB, NOT MAH AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT MODEL # IS BIM400, NOT BA400 AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT CATALOG # IS 93550, NOT 93333 AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT 510(K)# IS K131240, NOT K121317 AS PREVIOUSLY REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT PATIENT IDENTIFIER IS (B)(6) , NOT (B)(6) AS PREVIOUSLY REPORTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016, TO REMOVE THE INTERNAL MAGNET AND ABUTMENT WAS PLACED ON THE FIXTURE.

    Additional Manufacturer Narrative · 1

    THE PATIENT DATE OF BIRTH AND DATE OF INITIAL IMPLANTATION WAS NOT REPORTED. (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED A HEMATOMA AT THE IMPLANT SITE. SUBSEQUENTLY, THE HEMATOMA WAS DRAINED BY THE PATIENT'S PHYSICIAN (DATE NOT REPORTED). FOLLOWING THE PROCEDURE, THE SKINFLAP BROKE DOWN, RESULTING IN EXPOSURE OF THE INTERNAL MAGNET. REVISION SURGERY IS PLANNED; HOWEVER, IT IS UNKNOWN WHETHER THIS HAS YET TO OCCUR AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517597 COCHLEAR BAHA ATTACT SYSTEM LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention