BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10G MIMIX

    MDR report key: 2925108 · Received January 22, 2013

    Report

    Report Number
    0001032347-2013-00015
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 29, 2009
    Report Date
    January 10, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LOD
    PMA / PMN Number
    PK003494
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. A MAUDE SEARCH PERFORMED BY AN INTERNAL EMPLOYEE IDENTIFIED THAT A VOLUNTARY MAUDE REPORT WAS FILED ON A BIOMET MICROFIXATION PRODUCT THAT WAS NOT PREVIOUSLY REPORTED TO BIOMET MICROFIXATION. A NEUROSURGEON PERFORMED A CRANIOTOMY WHERE BONE CEMENT WAS USED. FOLLOWING THE SURGERY, IT WAS IDENTIFIED THAT THE BONE CEMENT HAD CRACKED IN FIVE PLACES AND THE PATIENT HAD A SPINAL FLUID LEAK. THE PATIENT HAD A REVISION SURGERY TO REPLACE THE CRACKED MIMIX AND REPAIR THE SPINAL FLUID LEAK. THE SPINAL FLUID LEAK WAS NOT CAUSED BY THE MIMIX. 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

    A MAUDE SEARCH PERFORMED BY AN INTERNAL EMPLOYEE IDENTIFIED A PATIENT HAD A REVISION SURGERY DUE TO MIMIX CRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29043 10G MIMIX BONE CEMENT LOD BIOMET MICROFIXATION N/A 335620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization