BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT

    MDR report key: 2211310 · Received August 3, 2011

    Report

    Report Number
    8030965-2011-00520
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    July 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K062564
    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

    DEVICE REPORT REC'D FROM (B)(6), INDICATES THE PT WAS TENDING TO HER CAT WHEN IT JUMPED UP AGAINST HER. SHE TURNED AS IF TO PREVENT IT FROM REACHING HER. IN THE PROCESS OF TWISTING, SHE HEARD A SNAPPING SOUND AND FELT IMMEDIATE PAIN IN HER LOWER RIGHT LEG. THE PT PRESENTED WITH PAIN IN THE RIGHT LOWER LEG. X-RAYS SHOWED A BROKEN PLATE THAT WAS PART OF A PREVIOUS FRACTURE FIXATION. THE BROKEN PLATE WAS REMOVED ON (B)(6) 2011 AND REPLACED WITH A SIMILAR PLATE. EVAL OF THE FRACTURE SITE DID NOT REVEAL ANY SIGN OF INFECTION OR SEPSIS. PATHOLOGY WAS SENT FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LCP DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT TI LCP DISTAL FEMUR PLATE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW