BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMMETRY SACROILIAC JOINT FUSION SYSTEM

    MDR report key: 3893784 · Received June 11, 2014

    Report

    Report Number
    3008875054-2014-00003
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ZYGA TECHNOLOGY INC.
    Product Code
    LXH
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORATION OF VITAL STRUCTURES, SPECIFICALLY THE GLUTEAL ARTERY, IS CALLED OUT IN THE WARNING SECTION OF THE SIMMETRY SACROILIAC JOINT FUSION SYSTEM PRODUCT INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    DURING SURGICAL ACCESS THE GLUTEAL ARTERY WAS IRRITATED SUCH THAT IT REQUIRED INTERVENTION ORDER TO STOP BLEEDING. NO SPECIFIC INSTRUMENT WAS IDENTIFIED AS CAUSING THE EVENT. HEMOSTASIS WAS EVENTUALLY ACHIEVED AND PT WAS STABILIZED AND LATER RELEASED FROM THE HOSPITAL. NO FURTHER SURGERY WAS REQUIRED; NO SIMMETRY IMPLANT WAS PLACED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346170 SIMMETRY SACROILIAC JOINT FUSION SYSTEM MANUAL SURGICAL INSTRUMENT LXH ZYGA TECHNOLOGY INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization