BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 2855003 · Received December 3, 2012

    Report

    Report Number
    2520274-2012-03465
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    October 1, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN ORIF HIP SURGERY. AT SIX WEEKS FOLLOWING THE SURGERY, UPON X-RAY, THE SURGEON FOUND ONE SCREW BROKEN. THE FRACTURE APPEARED TO BE UNITED. THE SURGEON NOTED GOOD PLATE TO BONE OPPOSITION. ON (B)(6) 2012, THE SURGEON PERFORMED A REVISION DUE TO NON-UNION. TWO ADDITIONAL SCREWS WERE FOUND BROKEN. ALL HARDWARE WAS EXPLANTED AND THE SURGEON REVISED THE PATIENT WITH A PEDI-HIP SCREW, STABILIZING THE ORIGINAL OSTEOTOMY. THIS IS REPORT # 4 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE PLATE KTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention