BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM

    MDR report key: 3820062 · Received May 20, 2014

    Report

    Report Number
    2520274-2014-11542
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KTW
    PMA / PMN Number
    PK011815
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. IMPLANT DATE: UNKNOWN DATE IN (B)(6) OF 2013. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A REVISION SURGERY DUE TO A BROKEN PROXIMAL HUMERUS PLATE AND A NONUNION. THE PATIENT WAS ORIGINALLY TREATED FOR A PROXIMAL HUMERUS FRACTURE IN (B)(6) 2013. ON AN UNKNOWN DATE, DURING A ROUTINE FOLLOW-UP AND EXTENSIVE EVALUATION, IT WAS CONFIRMED VIA X-RAY AND COMPUTERIZED TOMOGRAPHY (CT) SCAN THAT THE PATIENT HAD A NONUNION AND BROKEN PLATE; FURTHERMORE IT WAS CONFIRMED THAT THE PLATE WAS BROKEN AT TWO OF THE SCREW HOLES IN THE SHAFT OF THE PLATE. THE SURGEON EXPLANTED THE PROXIMAL HUMERUS PLATE AND ELEVEN SCREWS (A COMBINATION OF LOCKING SCREWS IN THE HEAD OF THE PLATE AND CORTICAL SCREWS IN THE SHAFT OF THE PLATE). THE PATIENT WAS REVISED TO A LONGER PLATE. THE PROCEDURE COMPLETED SUCCESSFULLY WITH NO HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300122 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT KTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention