BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSHAPE SOFT TISSUE FASTENER

    MDR report key: 2677225 · Received August 1, 2012

    Report

    Report Number
    3007593722-2012-00001
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Date of Event
    January 1, 2012
    Report Date
    July 31, 2012
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    MBI
    PMA / PMN Number
    K111471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT REMOVAL COMPLETED WITH NO ISSUES. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED FROM THIS INCIDENT. NO PART NUMBERS OR LOT NUMBERS WERE PROVIDED. THE DEVICE WAS DISCARDED BEFORE A REQUEST FOR EVALUATION COULD BE MADE, THEREFORE, NONE WAS DOCUMENTED. THERE IS A PRECAUTION IN THE PACKAGE INSERT THAT INFERS THIS TYPE OF EVENT CAN OCCUR: UNDER THE FIRST BULLET IN SECTION 5 STATES, "KNOWLEDGE OF APPROPRIATE SURGICAL TECHNIQUES, INSTRUMENTATION, PROPER SELECTION AND PLACEMENT OF IMPLANTS AND POSTOPERATIVE PATIENT CARE AND MANAGEMENT ARE ESSENTIAL TO A SUCCESSFUL OUTCOME ".

    Description of Event or Problem · 1

    PATIENT WAS SEVERAL MONTHS POST-OP FROM ACL SURGERY AND WAS COMPLAINING OF PAIN OVER TIBIAL SITE OF INSERTION. DURING THE PATIENT'S EXPLORATORY SURGERY, THE SURGEON FOUND THE IMPLANT NOT TO BE FLUSH WITH THE CORTICAL SURFACE. THE SURGEON REMOVED THE IMPLANT, AND BECAUSE THE PATIENT HAD SUCCESSFULLY COMPLETED REHABILITATION, THERE WAS NO NEED TO REPLACE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXOSHAPE SOFT TISSUE FASTENER SOFT TISSUE FASTENER MBI MEDSHAPE, INC. 1101-00-0730 THRU 1101-00-1230 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention