BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMMETRY ILIUM DECORTICATOR B

    MDR report key: 3832523 · Received March 17, 2014

    Report

    Report Number
    3008875054-2014-00002
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 20, 2014
    Report Date
    March 18, 2014
    Manufacturer
    ZYGA TECHNOLOGY INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    DURING JOINT PREPARATION FOR A SACROILIAC JOINT FUSION THE PHYSICIAN NOTED THAT A PORTION OF A SIMMETRY DECORTICATOR TIP BROKE OFF. THE PHYSICIAN DETERMINED THE FRAGMENT WAS NOT RETRIEVABLE; THEREFORE, IT REMAINS WITHIN THE PATIENT'S SACROILIAC JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157098 SIMMETRY ILIUM DECORTICATOR B MANUAL SURGICAL INSTRUMENT LXH ZYGA TECHNOLOGY INC. ZYG-10071-B 140018

    Patients

    Seq Age Sex Outcome Treatment
    1