BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM HEADLESS COMPRESSION

    MDR report key: 1853090 · Received September 22, 2010

    Report

    Report Number
    1719045-2010-00253
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K050636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. SUBJECT DEVICE WAS INSERTED AND REMOVED IN THE SAME PROCEDURE. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE SURGEON WAS INSERTING HEADLESS COMPRESSION SCREW AND THE THREADS PEELED AND WENT INTO THE BONE. SURGEON REMOVED THE SHAFT AND DUG OUT THE PIECES OF THE SEPARATED THREAD FROM THE BONE. SURGEON SELECTED A CANNULATED SCREW AND USED THE SAME HOLE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0MM HEADLESS COMPRESSION HEADLESS COMPRESSION SCREWS HWC SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR