BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEGA SPAN SPINOUS PROCESS PLATE SYSTEM

    MDR report key: 6932661 · Received October 9, 2017

    Report

    Report Number
    3005977257-2016-00001
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    February 22, 2016
    Report Date
    February 24, 2016
    Manufacturer
    SPINEFRONTIER INC.
    Product Code
    KWP
    PMA / PMN Number
    K102020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD FOR THE INSPAN PLATE PART #: 01-61006-1037, LOT; BH07: WAS REVIEWED FOLLOWING THE INCIDENT, NO NCMR, DEVIATIONS OR CAPAS RESULTED FROM THE MANUFACTURING OF LOT BH07. THE INSPAN INTERSPINOUS PLATE SYSTEM WAS SOLD NON-STERILE, THE END-USER IS RESPONSIBLE FOR ENSURING THAT THE DEVICE IS STERILIZED PRIOR TO USE. ADDITIONALLY, SPINEFRONTIER PROVIDES A CLEANING AND STERILIZATION IFU WHICH ADEQUATELY DESCRIBES THE CLEANING AND STERILIZATION PROCESSES. THE USER SITE COULD NOT PRODUCE CLEANING AND STERILIZATION RECORD FOR THE SET USED IN THIS SURGERY. CONSEQUENTLY, SPINEFRONTIER COULD NOT ESTABLISH IF THE SET WAS STERILIZED PRIOR TO SURGERY.

    Description of Event or Problem · 1

    SPINEFRONTIER RECEIVED INFORMATION FROM A DISTRIBUTOR STATING THAT AN (B)(6) MALE ILIF PATIENT PRESENTED WITH A SUPERFICIAL INFECTION ON (B)(6) 2016. THE DISTRIBUTOR REPORTED THAT 10X37MM INSPAN SLIM, SP PLATE WAS IMPLANTED ON (B)(6) 2016. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707998 VEGA SPAN SPINOUS PROCESS PLATE SYSTEM INSPAN SLIM, SP PLATE, 10.37MM KWP SPINEFRONTIER INC. NA BH07

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention