BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOSIS

    MDR report key: 6231413 · Received January 6, 2017

    Report

    Report Number
    0009610576-2017-00003
    Event Type
    Injury
    Date Received
    January 6, 2017
    Report Date
    December 7, 2016
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    MNI
    PMA / PMN Number
    PK031354
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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 DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, A SIMILAR DEVICE IS CLEARED IN THE U.S. UNDER 510K NUMBER K031354. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT SPINAL ARTHRODESIS PROCEDURE. SUBSEQUENTLY, PATIENT ALLEGES UNDERGOING AN UNSPECIFIED REOPERATION PROCEDURE APPROXIMATELY 4 YEARS POST-IMPLANTATION DUE TO LOWER BACK PROBLEMS AND AMBULATION DIFFICULTIES WITH PERMANENT NERVE DAMAGE OCCURRING APPROXIMATELY 3 YEARS POST-OP. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14287 UNKNOWN ORTHOSIS SPINAL PEDICAL FIXATION MNI BIOMET SPAIN, S.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S