BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/40MM

    MDR report key: 2921798 · Received January 18, 2013

    Report

    Report Number
    1719045-2013-00150
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 21, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS THE DEVICE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN ORIF OF A FRACTURED CALCANEUS AND MEDIAL MALLEOLUS ON AN UNKNOWN DATE. THE PATIENT REPORTED PAIN ON UNKNOWN DATE. THE PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. IT IS REPORTED THAT THE PATIENT'S BONE HAD HEALED AND NO NEW HARDWARE WAS IMPLANTED. THIS IS REPORT # 1 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28446 4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/40MM CANCELLOUS BONE SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention