BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW

    MDR report key: 2881986 · Received December 20, 2012

    Report

    Report Number
    2520274-2012-04097
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT NOT DIAGNOSIS. 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

    PATIENT PRESENTED WITH A NON HEALING FRACTURE STATUS POST ELBOW IMPLANT OF 1 PLATE AND 12 SCREWS. PATIENT RETURNED TO THE OR FOR HARDWARE REMOVAL OF THE ONE PLATE AND 12 SCREWS AND REVISED TO RADIAL HEAD PROSTHESIS. THIS IS 3 OF 13 REPORTS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW LOCKING SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention PLATE, SCREWS