BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/70MM

    MDR report key: 2942984 · Received February 5, 2013

    Report

    Report Number
    8030965-2013-00311
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDP
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH VA-LCP CURVED CONDYLAR PLATE AND SCREWS ON (B)(6) 2012. PATIENT PRESENTED WITH A NON-UNION OF DISTAL FEMUR FRACTURE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED TO VA-LCP CURVED CONDYLAR PLATE CONSTRUCT. THIS IS 7 OF 10 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47601 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/70MM VA LOCKING SCREW JDP SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention