BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2042173 · Received March 28, 2011

    Report

    Report Number
    2520274-2011-00079
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    February 25, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTY
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH EX-FIX FOR A MANDIBLE FRACTURE. ONE OF THE PINS BROKE POSTOPERATIVELY. REPORTEDLY, PATIENT WAS PUNCHED IN THE FACE. EX-FIX WAS REMOVED (B)(6) 2010 AND PATIENT WAS REVISED TO A MANDIBLE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI PIN HTY SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention