BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 11

    MDR report key: 3180031 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19396
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 28, 2013
    Report Date
    June 20, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    FROM THE COMMUNICATED ELEMENTS, NO ANALYSIS COULD BE CARRIED OUT BECAUSE NO SUFFICIENT INFORMATION WAS PROVIDED ( NO PRODUCT RETURNED, NO BATCH NUMBER COMMUNICATED). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CORAIL STEM FRACTURE DUE TO PATIENT FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281569 CORAIL AMT COLLAR SIZE 11 HIP STEM KWA DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention