BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS

    MDR report key: 2862091 · Received December 7, 2012

    Report

    Report Number
    1719045-2012-01270
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A TFN ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PAIN AND WAS RETURNED TO THE OR ON (B)(6) 2012. ALL HARDWARE WAS REMOVED AND NO ADDITIONAL HARDWARE WAS IMPLANTED. THIS REPORT IS NUMBER 3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS 5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention NAIL, BLADE