BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02917

    MDR report key: 3143624 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-02917
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT IN (B)(6) 2012 A PATIENT HAD A FALL AND BROKE HER LEFT HUMERUS. SHE WAS DIAGNOSED WITH A MULTI SEGMENTAL DISTAL HUMERUS WHICH WAS FIXED WITH SYNTHES IMPLANTS. AN OLECRANON OSTEOTOMY WAS PERFORMED TO POSITION THE PLATES PROPERLY. PATIENT WAS IMPLANTED WITH A LATERAL AND A MEDIAL PLATE. ONE YEAR POST OP THE PATIENT REPORTED HIGH LEVELS OF ASSOCIATED PAIN, RELIANCE ON MORPHINE FOR DAILY PAIN MANAGEMENT, AND LIMITED RANGE OF MOTION. THIS IS REPORT 1 OF 1 FOR COMPLAINT 41948 AND PERTAINS TO TWO HUMERAL PLATES OF UNKNOWN PART NUMBER AND UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243879 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR