BEUDAMED
    FDA Adverse Event Summary report: N

    MERCURY CLASSIC

    MDR report key: 5666141 · Received July 23, 2013

    Report

    Report Number
    3004893332-2013-00001
    Date Received
    July 23, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 11, 2013
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ORIGINAL SURGERY ON (B)(6) 2013 PERFORMED BY DR. (B)(6) WITH SPINAL ELEMENT'S, INC., MERCURY CLASSIC POLYAXIAL SCREWS. REVISION SURGERY PERFORMED BY DR. (B)(6) ON (B)(6) 2013 WITH SPINAL ELEMENTS, INC., MERCURY AND TI-BOND TLIF SETS. DR. (B)(6). (B)(6) SAID THAT SCREWS ARE LOOSE AND NEED TO BE TAKEN OUT. REP FOR REMOVAL CASE CONTACTED DR. (B)(6) WHO REFUSED TO PROVIDE X-RAYS. DR STATED THAT PT WAS NON-COMPLIANT AND WENT HUNTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344340 MERCURY CLASSIC POLYAXIAL SCREW NKB SPINAL ELEMENTS, INC. 62065-05X

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention