BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CLICK'X LOCKING CAP FOR TI 3-D HEAD

    MDR report key: 1944426 · Received December 28, 2010

    Report

    Report Number
    1719045-2010-00376
    Event Type
    Injury
    Date Received
    December 28, 2010
    Report Date
    December 2, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWP
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    LOT#: THIS INFORMATION HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    ATTORNEY ADVISED A PATIENT WITH PREVIOUS WORK RELATED INJURY (1999), A FUSION PROCEDURE AT L4-L5, L5-S1 WITH CLICK'X ON (B)(6) 2003, AND A PREVIOUS REVISION ON (B)(6) 2008 WITH NEW HARDWARE, PRESENTED TO THE SURGEON IN (B)(6) 2008 COMPLAINING OF PAIN, 'SQUEAKING' AND NUMBNESS IN THE RIGHT LEG. X-RAY TAKEN REVEALED THAT A RIGHT LOCKING CAP HAD COME OFF. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2008 AND SURGEON EXCHANGED AND PLACED A NEW LOCKING CAP. OP REPORTS STATE THAT THERE WAS NO PROBLEM WITH THE SCREW OR THE ROD WITHIN THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI CLICK'X LOCKING CAP FOR TI 3-D HEAD CLICK'X LOCKING CAP KWP SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention PEDICLE SCREW| 3-D HEAD