BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL HEAD 2 (PH2), UNKNOWN SIZE ROD

    MDR report key: 1881938 · Received October 12, 2010

    Report

    Report Number
    1530901-2010-00126
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    October 15, 2009
    Report Date
    October 12, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL SURGERY PROCEDURE USING THE PARAMOUNT PEDICAL SCREW SYSTEM, THE ROD BECAME DISASSEMBLED FROM THE POLYAXIAL SCREW HEAD DURING ROD TRANSFER. THE SURGEON REMOVED THE SCREW AND POLYAXIAL HEAD AND IMPLANTED A NEW SCREW, POLYHEAD AND SCREW. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYAXIAL HEAD 2 (PH2), UNKNOWN SIZE ROD PARAMOUNT MNI THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.