BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

    MDR report key: 4152774 · Received October 8, 2014

    Report

    Report Number
    3005099803-2014-03234
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MBI
    PMA / PMN Number
    K971139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT¿S ATTORNEY, A PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630716 BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BOSTON SCIENTIFIC - SPENCER UNK395

    Patients

    Seq Age Sex Outcome Treatment
    1 Other