BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLD SCREW LG 22MM STERILE

    MDR report key: 3943560 · Received April 30, 2014

    Report

    Report Number
    9615741-2014-00016
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 8, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    PMA / PMN Number
    K990622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED 'WHEN THE BOX WAS OPENED, THE INTERNAL PACKAGING WAS OPEN, THEREFORE, NOT GUARANTEEING STERILITY.' PRODUCT NOT IN CONTACT WITH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258551 BOLD SCREW LG 22MM STERILE NA HWC NEWDEAL SAS F51R

    Patients

    Seq Age Sex Outcome Treatment
    1