BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1912059 · Received December 1, 2010

    Report

    Report Number
    6000034-2010-00751
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AROUND THE FIXTURE SITE. IT WAS DETERMINED THAT THERE WAS A FAILURE TO OSSEOINTEGRATE. EXPLANTATION IS PLANNED BUT HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6), 2010. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT. NO EVIDENCE OF INFECTION WAS FOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention