BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2921582 · Received January 18, 2013

    Report

    Report Number
    2520274-2013-00415
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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

    CUSTOMER RECEIVED AN ORDER OF SCREWS ON (B)(6) 2012. UPON DELIVERY, CUSTOMER NOTICED THAT THE INFORMATION ON THE PACKAGING WAS CORRECT, ALTHOUGH THE SCREWS INSIDE WERE INCORRECT AND DID NOT MATCH THE INFORMATION ON THE PACKAGING. THIS IS 3 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27351 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1