BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP-PLT 4.5/5 LE 9HO L220 TAN

    MDR report key: 2193354 · Received July 29, 2011

    Report

    Report Number
    8030965-2011-00515
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K052390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 ONE OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP-PLT 4.5/5 LE 9HO L220 TAN :LCP PROXIMAL LATERAL PLATE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW