BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW

    MDR report key: 2020156 · Received March 7, 2011

    Report

    Report Number
    8030965-2011-00048
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE THE DATE OF MANUFACTURE. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION CAN BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT RECEIVED FROM (B)(6) INDICATES PT STATUS POST PLATE AND SCREW IMPLANTATION ON AN UNK DATE RETURNED TO SURGEON, AND IT WAS DISCOVERED THE SCREWS WERE BROKEN. SURGEON REMOVED THE HARDWARE AND REPLACED WITH ANOTHER PLATE AND SCREWS. SURGEON NOTED THE SCREWS BROKE WITH NO APPLIED LOADS. THIS IS FOUR OF FIVE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI LOCKING HEAD SCREW LOCKING SCREWS KTT SYNTHES GMBH NA 2653911

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention