BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR SPINE PACK

    MDR report key: 7876278 · Received September 14, 2018

    Report

    Report Number
    7876278
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    August 28, 2018
    Report Date
    August 30, 2018
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STERILITY ISSUE: HAIR STRAND WAS FOUND IN THE NEEDLE BOX THAT CAME WITH THE CMC ANTERIOR SPINE PACK. STERILE FIELD/SET-UP DISASSEMBLED AND NEW STERILE SUPPLIES AND INSTRUMENTATION OBTAINED AND OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719027 ANTERIOR SPINE PACK GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS CDAN02A

    Patients

    Seq Age Sex Outcome Treatment
    1