BEUDAMED
    FDA Adverse Event Other Summary report: N

    LACTOSORB 1.5MM X SHAPE XT PLATE

    MDR report key: 1056625 · Received June 3, 2008

    Report

    Report Number
    1032347-2008-00027
    Event Type
    Other
    Date Received
    June 3, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    HRS
    PMA / PMN Number
    K955729
    Adverse Event
    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. 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.

    Description of Event or Problem · 1

    DOCTOR IMPLANTED LACTOSORB PRODUCT WHEN CLOSING A PATIENT'S CRANIAL ON (B) (6) 2008. INFECTION WAS CAUSED BY (B) (6) AND THE PATIENT WAS TREATED WITH AN ANTIBIOTIC ON (B) (6) 2008. THERE WAS NO IMPROVEMENT WITH HIM AND THE LACTOSORB WAS REMOVED ON (B) (6) 2008. HE WAS STILL TREATED WITH ANTIBIOTIC AS OF (B) (6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB 1.5MM X SHAPE XT PLATE RESORBABLE PLATE HRS BIOMET MICROFIXATION, INC. 244540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization AND SCREWS WERE USED| OTHER PLATES