BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0X7MM HT SD X-DR SCR,

    MDR report key: 1821611 · Received August 31, 2010

    Report

    Report Number
    1032347-2010-00144
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    June 22, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K953385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS ABOUT (B)(6). THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO SCREWS BROKE WHILE BEING IMPLANTED. THE TIP OF THE SCREWS REMAIN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0X7MM HT SD X-DR SCR, BONE SCREW HWC BIOMET MICROFIXATION 075410

    Patients

    Seq Age Sex Outcome Treatment
    1