BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE

    MDR report key: 4883068 · Received June 24, 2015

    Report

    Report Number
    MW5043364
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    April 13, 2015
    Report Date
    June 24, 2015
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    KWQ
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A SCREW IN A SAPPHIRE UNIT PRODUCED BY SPINAL ELEMENTS BACKED OUT WITHIN TWO WEEKS OF THE FUSION SURGERY. THE SURGERY WAS (B)(6) 2015 AND AN X-RAY ON (B)(6) SHOWED A SCREW HAD BACKED OUT. A REVISION SURGERY WAS PERFORMED (B)(6) 2015 TO REMOVE THE SCREW AND REPLACE IT WITH A RESCUE SCREW. THERE WAS A HIGHER SIGNIFICANCE OF PROBLEMS WITH THE SECOND SURGERY WITH SWELLING AND INABILITY TO TALK. I WAS NOT NOTIFIED WHEN THE SCREW BACKED OUT ORIGINALLY OR LATER BY THE PHYSICIAN WHEN THE X-RAY SHOWED THE SCREW HAD BACKED OUT. THE FIRST TIME IT WAS OUT 2MM AND THE SECOND TIME 5MM. I WAS TOLD WHEN I WENT FOR A FOLLOW UP VISIT THAT REVISION SURGERY WAS NECESSARY BY THE PHYSICIAN WITH NO WARNING OF THE HIGHER RISKS INVOLVED BECAUSE OF THE CLOSENESS OF THE TWO SURGERIES. THE MANUFACTURER'S REPRESENTATIVE WAS PRESENT AT THE (B)(6) 2015 SURGERY TO RETRIEVE THE SCREW TO RETURN IT TO THE MANUFACTURER, SPINAL ELEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407857 SAPPHIRE SAPPHIRE KWQ SPINAL ELEMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R OMEPRAZOLE| HYDROCOD/ACETA 5-325| ESCUTAKIORAN| TRAZODONE| LOPERAMIDE| RX MEDS: PREMARIN VAGINAL CREAM .625