BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAND INF MED DISTRACTOR

    MDR report key: 1364016 · Received January 15, 2009

    Report

    Report Number
    1032347-2009-00007
    Event Type
    Other
    Date Received
    January 15, 2009
    Date of Event
    December 19, 2008
    Report Date
    December 19, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K030425
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR USED THE LACTOSORB HEAT PEN TO SHAPE THE DEVICE. IFU INDICATES THE RESORBABLE PLATES CAN BE HEATED AND SHAPED AS DESIRED UP TO AND INCLUDING THREE TIMES USING A LACTOSORB HEAT PACK OR A HOT STERILE SALINE/WATER BATH. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A F/U REPORT WILL BE SENT. THIS WAS A SECOND REVISION SURGERY, SEE 1032347-2009-0006 FOR THE FIRST REVISION SURGERY INFO. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE.

    Description of Event or Problem · 1

    DISTRACTION DEVICE IMPLANTED ON (B) (6) 2008. REVISION SURGERY DONE (B) (6)2008, AS THE HOUSING BROKE ON THE RIGHT SIDE. SECOND REVISION SURGERY DONE (B) (6)2008 AS THE RIGHT SIDE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAND INF MED DISTRACTOR RESORBABLE DISTRACTOR JEY BIOMET MICROFIXATION 666300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization PART NUMBER AND QUANTITY OF THE PLATES IS UNK.| SCREWS WERE USED TO FIXATE THE DISTRACTION PLATES,