BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SELF-TAPPING 45MM

    MDR report key: 2083414 · Received April 29, 2011

    Report

    Report Number
    8030965-2011-00188
    Event Type
    Injury
    Date Received
    April 29, 2011
    Report Date
    April 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. MANUFACTURE DATE HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A 3.5MM LCP PROXIMAL HUMERUS PLATE AND 13 LOCKING SCREWS. X-RAYS TAKEN ON A FOLLOW-UP VISIT NOTED THE SCREWS TO BE BACKING OUT AND THE PLATE TO BE LIFTING FROM THE BONE. PATIENT WAS RETURNED TO THE OPERATING ROOM AND HARDWARE WAS REMOVED. THIS REPORT IS #11 OF 14 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LOCKING SCREW SELF-TAPPING 45MM 3.5MM LOCKING SCREW SELF-TAPPING 45MM KTT SYNTHES GMBH NA 2401816

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCREWS| PLATE