BEUDAMED
    FDA Adverse Event Death Summary report: N

    HFN LH 130 DEG 11MM X 340MM

    MDR report key: 5489862 · Received March 9, 2016

    Report

    Report Number
    0001825034-2016-00845
    Event Type
    Death
    Date Received
    March 9, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 29, 2016
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00844 / 00845). REQUESTED BUT NOT RETURNED BY HOSPITAL.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP FRACTURE FIXATION PROCEDURE ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO NAIL FRACTURE AFTER A PATIENT FALL. PATIENT EXPIRED ON (B)(6) 2016 DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144397 HFN LH 130 DEG 11MM X 340MM FIXATION, ROD HSB BIOMET TRAUMA N/A DNCBZN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| R