BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.5X4MM HT SD X-DRIVE SCREW

    MDR report key: 1313208 · Received February 12, 2009

    Report

    Report Number
    1032347-2009-00016
    Event Type
    Other
    Date Received
    February 12, 2009
    Date of Event
    February 2, 2009
    Report Date
    January 22, 2009
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K953385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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. TWO PART NUMBERS OF SCREWS PULLED OUT, SEE 1032347-2008-00015.

    Description of Event or Problem · 1

    PATIENT HAD HARD TISSUE REPLACEMENT (HTR) IMPLANTED (B)(6) 2008. THE BRAIN WAS SWOLLEN, A VENTRICULAR CATHETER WAS USED TO DRAIN CSF. ABOUT A MONTH LATER, NOTICED THE HTR IMPLANT WAS BULGING OUT OF THE SKIN, HAD LIFTED UP ABOUT 1CM. A 3D CT SCAN WAS DONE, SAW WHERE ONE 2 HOLE PLATE AND THE 6 HOLE PLATE HAD POPPED OFF OF THE IMPLANT, STILL FIXATED TO THE SKULL. REVISION SURGERY DONE (B)(6)2009, REMOVED ALL PLATES AND SCREWS, PUT IN ANOTHER CATHETER, DRAINED MORE CSF, CLOSED WITH 3 PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5X4MM HT SD X-DRIVE SCREW BONE SCREW JEY BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization SCREWS FOR THESE PLATES WERE USED TO FIXATE THE| HTR IMPLANT.| 1 01-7050 PLATE| 2 01-7347 PLATES