BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREW

    MDR report key: 2193340 · Received July 29, 2011

    Report

    Report Number
    2520274-2011-00528
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    A DEVICE REPORT RECEIVED FROM SYNTHES (B)(4) REPORTED: PATIENT STATUS POST IMPLANTATION ON (B)(6) 2010, APPROXIMATELY ONE YEAR POST OP, UNDERWENT A REOPERATION FOR AN UNKNOWN REASON. THE PLATE AND SCREWS WERE INTACT PRIOR TO REOPERATION. DURING THE PROCEDURE SURGEON WAS UNABLE TO REMOVE 2 SCREWS FROM PLATE. PLATE WITH 2 SCREWS REMAIN IN PATIENT. THIS IS THREE OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK - SCREW :SCREW HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE