BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORLOK(R) SOFT TISSUE ANCHOR

    MDR report key: 2060265 · Received April 15, 2011

    Report

    Report Number
    1043534-2011-00155
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 27, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MBI
    PMA / PMN Number
    K953264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00156.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA / ADDITIONAL INFORMATION RECEIVED (B)(4) 2011: THE RISK MGR ADVISES THERE WAS NO DELAY IN SURGERY THAT CAUSED OR COULD HAVE CAUSED A RISK OR SERIOUS INJURY TO THE PATIENT; THEREFORE, THIS MEDWATCH 3500A WAS NOT REQUIRED. THIS IS THE SAME EVENT AS 1043534-2011-00156.

    Description of Event or Problem · 1

    ALLEGEDLY THIS EVENT CAUSE A DELAY IN SURGERY TIME BY 30 MINS.

    Description of Event or Problem · 1

    ALLEGEDLY, THIS EVENT CAUSE A DELAY IN SURGERY TIME BY 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHORLOK(R) SOFT TISSUE ANCHOR SOFT TISSUE ANCHOR MBI WRIGHT MEDICAL TECHNOLOGY, INC. 03016100323

    Patients

    Seq Age Sex Outcome Treatment
    1 Other