BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW

    MDR report key: 2234013 · Received August 31, 2011

    Report

    Report Number
    8030965-2011-00585
    Event Type
    Injury
    Date Received
    August 31, 2011
    Report Date
    August 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, PT FELL ON (B)(6) 2011. SURGERY PERFORMED THE FOLLOWING DAY ON (B)(6) 2011. SURGEON WAS SATISFIED WITH THE OPERATION, NOT A PERFECT REDUCTION, HOWEVER, GOOD ALIGNMENT. PT PRESENTED TO HOSPITAL ON (B)(6) 2011 FOR X-RAYS. X-RAYS SHOWED DISTAL SCREWS LOOSENING WITH SUSTAINED REDUCTION. PT PRESENTED TO HOSPITAL ON (B)(6) 2011 AND SURGEON NOTED LOSS OF REDUCTION AND LOOSENING OF DISTAL SCREWS. VA LCP CONDYLAR PLATE WAS REMOVED ON (B)(6) 2011 AND REPLACED WITH A LISS DF PLATE WITH A FEMUR STRUT. DURING THE REVISION, SURGEON NOTED 4 OF THE 5 DISTAL SCREWS WERE LOOSE AND REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW LOCKING SCREW HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCREWS| PLATE