BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PACK

    MDR report key: 7893082 · Received September 20, 2018

    Report

    Report Number
    7893082
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Date of Event
    September 4, 2018
    Report Date
    September 12, 2018
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    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

    FRESH 10 BLADE FROM POSTERIOR SPINE PACK BROKE. SURGEON STATES THAT HE WAS NOT PUTTING STRESS ON THE BLADE AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733710 CUSTOM PACK GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA