BEUDAMED
    FDA Adverse Event Summary report: N

    1 MM SCREW 1.0MM X 3.0MM

    MDR report key: 2100023 · Received May 24, 2011

    Report

    Report Number
    1032347-2011-00074
    Date Received
    May 24, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K953385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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 THAT WHEN THE DOCTOR WAS INSERTING THE SCREW, THE SCREW BROKE AND THE TIP OF THE SCREW REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 MM SCREW 1.0MM X 3.0MM BONE SCREW HWC BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1