BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 2954963 · Received February 11, 2013

    Report

    Report Number
    1719045-2013-00283
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A CRANIOTOMY SURGERY PERFORMED ON (B)(6) 2013, THREE SCREWS HAD THE HEADS SHEAR OFF DURING INSERTION. THE SURGEON WAS ABLE TO GET ALL OF THE PIECES OUT AND NOTHING WAS LEFT IN THE PATIENT. NO ISSUES WERE REPORTED WITH THE PATIENT OR PROLONGATION OF THE SURGERY. THE HOSPITAL THREW ALL OF THE PIECES AWAY. THIS REPORT IS NUMBER 3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59105 TI MATRIXNEURO SCREW SELF-DRILLING 4MM SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR