BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINK(R) MP(TM) FIXATION SCREW

    MDR report key: 2110158 · Received June 1, 2011

    Report

    Report Number
    9610548-2011-00007
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 27, 2011
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    JDI
    PMA / PMN Number
    K955296
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR 17294538 LOT NO: 0914173. PRODUCT NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED; UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) IS REPORTING ON BEHALF OF THE MANUFACTURER, (B)(4). THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500 HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00247, 00249.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINK(R) MP(TM) FIXATION SCREW HIP COMPONENT JDI WALDEMAR LINK GMBH & CO. KG 0914173

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R