BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 5015691 · Received August 19, 2015

    Report

    Report Number
    0001032347-2015-00357
    Event Type
    Death
    Date Received
    August 19, 2015
    Date of Event
    July 20, 2015
    Report Date
    September 8, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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. DEVICE NOT RETURNED; NO EVALUATION WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER LIMITED INFORMATION WAS PROVIDED DUE TO PROTECTION OF PRIVACY. THE PATIENT'S AGE AND GENDER WERE PROVIDED. THE DISTRIBUTOR STATES THE SALES REPRESENTATIVE RESPONDED ¿THE SURGEON REPORTED, THAT THE PATIENT SUFFERED A POSTOPERATIVE HYPERTENSIVE CRISIS AND THAT THE PROGRESSED BLEEDINGS, WHICH LEAD TO DEATH OF THE PATIENT, ARE NOT MANDATORY IN CONNECTION WITH THE SURGERY. THE PATIENT DIED DUE TO COAGULATION PROBLEMS.¿

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT DIED ONE DAY POSTOPERATIVE AFTER A HARD TISSUE REPLACEMENT (HTR) SURGERY. THE SURGEON REPORTED "THE PATIENT SUFFERED A POSTOPERATIVE HYPERTENSIVE CRISIS AND THAT THE PROGRESSED BLEEDINGS, WHICH LEAD TO DEATH OF THE PATIENT ARE NOT MANDATORY IN CONNECTION WITH THE SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547562 HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT HTR PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT KKY BIOMET MICROFIXATION N/A 618660

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death