BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02522

    MDR report key: 3111761 · Received May 14, 2013

    Report

    Report Number
    2520274-2013-02522
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    July 12, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2012 THE PRODUCT MANAGER REQUESTED POST-LAUNCH FEEDBACK FROM THE CONSULTANTS REGARDING THE 3.5MM LOW PROFILE SCREW. A CONSULTANT REPLIED STATING THAT WHILE RESPONSE HAS BEEN POSITIVE, HE NOTED THAT THERE WERE A COUPLE OF SCREWS THAT WERE PARTIALLY STRIPPED DURING INSERTION. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4) AND COVERS BOTH OF THE AFOREMENTIONED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212106 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1