BEUDAMED
    FDA Adverse Event Summary report: N

    CORAL PEDICLE SCREW SYSTEM

    MDR report key: 1591655 · Received January 20, 2010

    Report

    Report Number
    1530901-2009-00030
    Date Received
    January 20, 2010
    Date of Event
    December 22, 2009
    Report Date
    January 18, 2010
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    NKB
    PMA / PMN Number
    K070962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS ORIGINALLY REPORTED TO THEKEN SPINE QC BY ONE OF THEKEN'S FIELD CLINICAL ENGINEERS. SHORTLY AFTER THAT WE RECEIVED A COPY OF THE HOSPITAL'S REPORT THAT HAD BEEN SUBMITTED TO THE FDA (REFERENCED AS THE INITIAL REPORTER IN THIS CASE). CURRENTLY THE IMPLANT IS STILL IN POSSESSION OF THE HOSPITAL WHILE THEIR INVESTIGATION IS BEING CONDUCTED. THE DEVICE HISTORY RECORD FOR THIS BATCH OF SCREWS WAS EXAMINED AND DID NOT INDICATE ANY NONCONFORMANCES OR ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT.

    Description of Event or Problem · 1

    WHILE REDIRECTING THE SCREW HEAD, THE COLLET SHEARED AND THE SEAT CAME OFF OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAL PEDICLE SCREW SYSTEM PEDICLE SCREW FIXATION SYSTEM NKB THEKEN SPINE LLC 18-12-7540 W10966

    Patients

    Seq Age Sex Outcome Treatment
    1