BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

    MDR report key: 2832375 · Received November 14, 2012

    Report

    Report Number
    3005099803-2012-05211
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MBI
    PMA / PMN Number
    K971139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PRECISION SPEEDTAC TRANSVAGINAL ANCHOR SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2003. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED UNSPECIFIED COMPLICATIONS. ALL OTHER INFORMATION IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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