BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2707552 · Received August 15, 2012

    Report

    Report Number
    2520274-2012-01590
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Report Date
    July 20, 2012
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    REPORTED TO CONSULTANT: ON THREE SEPARATE OCCASIONS WITH THREE SEPARATE PTS, SURGEON IMPLANTED A CSLP VARIABLE ANGLE PLATE WITH VARIABLE ANGLE QUICK LOCK SCREWS. IN ALL THREE CASES, A SCREW BACKED OUT AT THE BOTTOM OF THE PLATE. NO ADD'L INFO WAS AVAILABLE. ADD'L INFO HAS BEEN REQUESTED. THIS EVENT IS FOR PT #3, THIS IS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1