BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT

    MDR report key: 3761301 · Received April 21, 2014

    Report

    Report Number
    0001032347-2014-00134
    Event Type
    Injury
    Date Received
    April 21, 2014
    Report Date
    April 4, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GXN
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. REVIEW OF DEVICE HISTORY RECORDS SHOW THE IMPLANT WAS 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

    THE DISTRIBUTOR REPORTS A PATIENT HAS DEVELOPED A BRAIN INFECTION, THE SURGEON HAS INDICATED THE IMPLANTS WILL BE REMOVED. THE DATE OF THE REVISION SURGERY HAS NOT BEEN PROVIDED AT THIS TIME. FILE ONE OF THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240095 HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT HTR-PMI LF FRT ORB GXN BIOMET MICROFIXATION N/A 357140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R