BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER INC.

    MDR report key: 2892109 · Received December 26, 2012

    Report

    Report Number
    2892109
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 17, 2012
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGERY HERE AT (B)(6) ON (B)(6) 2012 FOR A SHOULDER ROTATOR CUFF TEAR. THE REPAIR INVOLVED PLACING A MESH GRAFT IN THE SHOULDER. ON (B)(6) 2012, PT RETURNED TO SURGERY FOR A SURGICAL SITE INFECTION, WHICH CONSISTED OF IRRIGATION, DEBRIDEMENT OF PREVIOUS SURGICAL SITE WITH REMOVAL OF INFECTED GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER INC. GRAFT JACKET KWS TORNIER INC CONEXA T00100-01B

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization