BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR

    MDR report key: 2429058 · Received January 26, 2012

    Report

    Report Number
    0001032347-2012-00008
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 24, 2012
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR WAS ABLE TO IMPLANT THE DEVICE, THE SURGERY WAS DELAY AS HE MODIFIED THE DEVICE SO THAT IT FIT THE PATIENT. 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

    THE HTR WAS EXPLANTED DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTR HARD TISSUE REPLACEMENT KKY BIOMET MICROFIXATION N/A 342750

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization