BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 7517486 · Received May 16, 2018

    Report

    Report Number
    3012916784-2018-00004
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    February 6, 2018
    Report Date
    May 16, 2018
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IMAGING USED TO GENERATE THE FHA AND PSV REPORTS WERE DISTORTED. THIS AFFECTED SUPINE PELVIC TILT, OPS ACETABULAR GUIDE ORIENTATION AND ACETABULAR CUP SIZING. THE OPS ACETABULAR GUIDE WAS NOT SUPPLIED FOR THIS CASE AS THE SURGEON NEVER PROVIDED CONFIRMATION OF THE PRE OPERATIVE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360507 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD N/A EBE_EL_10124

    Patients

    Seq Age Sex Outcome Treatment
    1