BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5867631 · Received August 11, 2016

    Report

    Report Number
    6000034-2016-01526
    Event Type
    Injury
    Date Received
    August 11, 2016
    Report Date
    July 20, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PREVIOUS MDRS WERE FILED INADVERTENTLY. PER THE CLINIC, THERE WAS NEVER ANY SIGN OF INFECTIONS AND THEREFORE NO ANTIBIOTICS WERE ADMINISTERED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CLINIC, THE PATIENT WAS TREATED WITH THE ANTIBIOTICS (DATE AND DURATION NOT REPORTED) FOR THE RECURRENT STAPH INFECTION. CORRECTION: THE CORRECT PMA/510(K) IS, K100360; NOT P100360 AS PREVIOUSLY REPORTED. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT STAPH INFECTION AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522580 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention