BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 2012823 · Received March 3, 2011

    Report

    Report Number
    8030965-2011-00041
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 5, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE WAS NOT EXPLANTED. 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 COMPLETED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM AUSTRIA INDICATES A SURGEON PLACED FOUR MATRIX SCREWS AT LEVELS L5-S1, HE THEN REMOVED THE INTERVERTEBRAL DISC AND PLACED A T-PAL CAGE. SURGEON THEN PLACED THE RODS ALONG WITH FOUR MATRIX LOCKING CAPS LOCKING WITH A TORQUE LIMITER. AN X-RAY WAS TAKEN SHOWING THE CAGE NEEDED REPOSITIONING. SURGEON COULD NOT UNLOCK THREE OF THE FOUR LOCKING CAPS. SURGEON COULD NOT REPOSITION THE T-PAL CAGE, HE THEN RE-TIGHTENED THE ONE LOCKING CAP HE COULD LOOSEN AND COMPLETED THE PROCEDURE. THIS IS THREE OF SIX REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MATRIX LOCKING CAP MATRIX LOCKING CAP NKB SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR SCREW