BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 CANCELLOUS BONE SCREW 16MM

    MDR report key: 1984068 · Received January 14, 2011

    Report

    Report Number
    2249697-2011-00052
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWC
    PMA / PMN Number
    K894124
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORNER OF THE STERILE PACKAGE STUCK TO THE PLASTIC CASE. THE SURGEON USED A SPARE PRODUCT INSTEAD OF IT AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5 CANCELLOUS BONE SCREW 16MM IMPLANT HWC STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention