BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM CANNULATED VA LOCKING SCREW/90MM

    MDR report key: 3082056 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-02182
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    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, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PATIENT REQUIRED HARDWARE REMOVAL OF A RIGHT DISTAL FEMUR FRACTURE. THIS WAS DUE TO A NON-UNION AND INFECTION. IT WAS REPORTED THAT THE PLATE WAS BROKEN BETWEEN THE SECOND COMBI HOLES BY THE DISTAL HEAD. THREE SCREWS WERE REMOVED FROM THE SHAFT AND FIVE FROM THE HEAD. NONE OF THE SCREWS WERE BROKEN. THE PATIENT WAS FLUSHED OUT AND AN EXTERNAL FIXATOR WAS PLACED. THIS IS REPORT 5 OF 9 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183687 5.0MM CANNULATED VA LOCKING SCREW/90MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention