BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI CORTEX SCREW, SELF-TAPPING 8MM

    MDR report key: 2143626 · Received June 3, 2011

    Report

    Report Number
    8030965-2011-00268
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Report Date
    May 11, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SCREW SHAFT REMAINS IMPLANTED. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE MEASURABLE DIMENSION OF THE BROKEN AND INTACT SCREW WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO-ASIF SPECS. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MFG PAPERS WAS NOT POSSIBLE, AS THE LOT NUMBER WAS NOT PROVIDED. THE MICROSCOPIC VIEW OF THE BROKEN SURFACES DID NOT SHOW ANY ANOMALIES OF MATERIAL STRUCTURE. NO PRODUCT FAULT COULD BE DETECTED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER. NO ADD'L INFO IS AVAILABLE.

    Description of Event or Problem · 1

    DURING SCREW INSERTION, THE SCREW WAS UNDERGOING COMPRESSION THROUGH A PLATE, WHEN THE HEAD BROKE. THE BROKEN SCREW HEAD WAS REMOVED. X-RAYS SHOWED THAT THE THREADED SHAFT REMAINS IN THE BONE. IT IS UNK IF THE SCREW SHAFT WILL BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5MM TI CORTEX SCREW, SELF-TAPPING 8MM CORTEX SCREW, SELF-TAPPING MQN SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1