BEUDAMED
    FDA Adverse Event Summary report: N

    2.4 SL 8 HOLE, X PLATE

    MDR report key: 1882580 · Received October 26, 2010

    Report

    Report Number
    1032347-2010-00184
    Date Received
    October 26, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K011076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. IFU STATES "CARE MUST BE TAKEN TO ACHIEVE THE APPROPRIATE CONTOUR WITH AS FEW BENDS AS POSSIBLE. REPEATED BENDING OF TITANIUM INCREASES THE RISK OF FRACTURE." 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 THE DOCTOR WAS BENDING THE PLATE TO CONFORM TO THE STERNUM AND THE PLATE BROKE. THE SURGERY WAS DELAY ABOUT 30 MINUTES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4 SL 8 HOLE, X PLATE BONE PLATE HWC BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization