BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0MM TI CORTEX SCREW SELF-TAPPING 11MM

    MDR report key: 3031398 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-00860
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND 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

    DURING A PROCEDURE, SURGEON WAS PERFORMING FINAL TIGHTENING AND THE HEAD OF THE CORTEX SCREW BROKE OFF LEAVING THE SHAFT IN THE PATIENTS BONE. THE SCREW HEAD WAS RETRIEVED. SURGEON DETERMINED LEAVING THE BROKEN SCREW SHAFT IMPLANTED IN THE BONE OUTWEIGHED THE RISKS INVOLVED IN TRYING TO RETRIEVE THE BROKEN SHAFT. SURGEON WAS SATISFIED WITH ANATOMIC REDUCTION AND FIXATION PROVIDED BY ADDITIONAL SCREWS. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133614 1.0MM TI CORTEX SCREW SELF-TAPPING 11MM HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR