BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2771942 · Received September 28, 2012

    Report

    Report Number
    2520274-2012-02083
    Event Type
    Injury
    Date Received
    September 28, 2012
    Report Date
    August 31, 2012
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH A VA-LCP DHP PLATE ON AN UNKNOWN DATE. PATIENT EXPERIENCED A SEVERE SPASM DUE TO PARKINSON'S DISEASE AND THE PLATE BROKE POST OPERATIVELY ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO OPERATING ROOM, DATE UNKNOWN, AND THE PLACE WAS REMOVED. THIS IS 2 OF 2 REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SCREW| PLATE