BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,2.4X10MM CANCELOUS LOCKNG

    MDR report key: 2033232 · Received March 30, 2011

    Report

    Report Number
    1032347-2011-00044
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K011076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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. THERE WERE PLATES AND SCREWS IMPLANTED AND EXPLANTED IN THE SAME PATIENT, SEE MDRS 1032347-2011-00043 TO 45.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PLATES AND SCREWS IMPLANTED FOR STERNAL CLOSURE ON (B)(6) 2011. ON (B)(6) 2011 REVISION SURGERY OCCURRED, AS X-RAY SHOWED THE TOP SCREWS WERE LOOSE AND PLACE WAS COMING APART FROM STERNUM. DOCTOR FIXATED THE PATIENT WITH PLATES AND WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW,2.4X10MM CANCELOUS LOCKNG BONE SCREW HWC BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization