BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2800412 · Received October 17, 2012

    Report

    Report Number
    2520274-2012-02303
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 18, 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 COMPLETE. 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)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED. PT IMPLANTED WITH VA-LCP PLATE ON (B)(6) 2012 EXPERIENCED A FALL AND THE PLATE WAS BROKEN, DATE UNK. PT RETURNED TO OPERATING ROOM ON (B)(6) 2012, HARDWARE WAS REMOVED. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention SCREW| PLATE