BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM METAPHYSEAL SCR SLF-TPNGW/T8 STRDRV RECESS/28MM

    MDR report key: 3151306 · Received June 7, 2013

    Report

    Report Number
    2520274-2013-03180
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K120854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A PATIENT WHO EXPERIENCED A DISTAL HUMERUS FRACTURE ON AN UNSPECIFIED DATE. ON (B)(6) 2013, THE SURGEON IMPLANTED A MEDIAL VARIABLE ANGLE ELBOW PLATE ALONG WITH 2.7 MM METAPHYSEAL SCREWS INSTEAD OF THE RECOMMENDED 3.5 MM CORTICAL SCREWS. THE SCREWS WENT COMPLETELY THROUGH THE PLATE, PULLING THE PLATE OFF THE BONE AND LEADING TO A NON-UNION. THE PATIENT WAS REVISED ON (B)(6) 2013. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252777 2.7MM METAPHYSEAL SCR SLF-TPNGW/T8 STRDRV RECESS/28MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention