BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXEL PROXIMAL ULNA

    MDR report key: 6980301 · Received October 26, 2017

    Report

    Report Number
    0001822565-2017-07441
    Event Type
    Injury
    Date Received
    October 26, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KXE
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS WE DO NOT HAVE REPORTING RESPONSIBILITY FOR THIS COMPLAINT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS BEING CONSIDERED FOR A REVISION TO ADDRESS UNKNOWN ISSUE(S). NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758346 UNKNOWN NEXEL PROXIMAL ULNA PROSTHESIS, EXTREMITY KXE ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R