BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.2MM TI CLICK'X MONOAXIAL PEDICLE SCREW 50MM THRD LENGTH

    MDR report key: 1667026 · Received April 21, 2010

    Report

    Report Number
    1719045-2010-00071
    Event Type
    Injury
    Date Received
    April 21, 2010
    Report Date
    March 22, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. DEVICES RECEIVED. A LIST OF THE LOT NUMBERS AND MANUFACTURING DATES ARE AS FOLLOWS: 1362907, 10/08/2005. 1254013, 06/04/2004. 1362906, 10/08/2005. LOT NUMBERS WERE OBTAINED FROM DEVICES RECEIVED. APPROXIMATE IMPLANT DATE - (B) (6) 2007. SUBJECT DEVICES HAVE BEEN RECEIVED AND ARE CURRENTLY IN THE EVALUATION PROCESS. DATE OF MANUFACTURE WAS DETERMINED FROM LOT NUMBERS OBTAINED FROM DEVICES RECEIVED.

    Description of Event or Problem · 1

    PATIENT STATUS POST REVISION OF FUSION AND EXPERIENCED LATE OPERATIVE SITE PAIN. X-RAY SHOWED SCREW AS PROMINENT AND CLICK'X LOCKING CAPS NOTED TO BE LOOSE AT THE LOWER PORTION OF THE CONSTRUCT. THE DUAL OPENING USS SYSTEM AND CLICK'X MONOAXIAL SYSTEM CONSTRUCT WAS REMOVED AND PATIENT HAD FUSED AT T4-L1. ADDITIONAL SCREWS WERE RECEIVED FOR INVESTIGATION. THE HOSPITAL WAS UNABLE TO IDENTIFY WHICH SCREW WAS ASSOCIATED WITH THE REPORTED EVENT. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.2MM TI CLICK'X MONOAXIAL PEDICLE SCREW 50MM THRD LENGTH CLICK'X MONOAXIAL PEDICLE SCREWS NKB SYNTHES MONUMENT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention CLICK'X LOCKING CAPS| DUAL OPENING USS SCREWS