BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PH3 HEAD (03-3020-01)

    MDR report key: 1963804 · Received December 22, 2010

    Report

    Report Number
    1530901-2010-00145
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 22, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE REPORTER STATED THAT A PT WHO HAD L4-S1 LEFT POSTERIOR FUSION SPINAL SURGERY ON (B)(6), 2010 USING THE PARAMOUNT PEDICLE SCREW SYSTEM, COMPLAINED AFTER THE SURGERY THAT SHE EXPERIENCED SUDDEN SHARP PAINS IN HER THIGH. MRI IMAGING SHOWED THAT THE SCREW AT VERTEBRAL LEVEL S1 HAD BEEN PLACED SO THAT IT WAS PARTIALLY IN THE FORAMEN. ON (B)(6), 2010, THE PT HAD A SECOND SPINAL SURGERY PROCEDURE TO REMOVE AND REPOSITION THIS S1 SCREW. DURING THIS PROCEDURE, THE SURGEON TOOK AN X-RAY OF THE FINAL CONSTRUCT AND OBSERVED THAT AT VERTEBRAL LEVEL L5, POLYAXIAL HEAD OF THE SCREW HAD DISCONNECTED FROM THE SCREW SHAFT. THIS SCREW WAS REMOVED. THE SURGEON THEN ELECTED TO REMOVE THE ENTIRE PARAMOUNT SYSTEM CONSTRUCT, AND TO REPLACE IT WITH ANOTHER PEDICLE SCREW SYSTEM (CORAL PEDICLE SCREW SYSTEM). THE FOLLOWING IMPLANTED PARAMOUNT DEVICES, WHICH HAD NOT MALFUNCTIONED, WERE REMOVED AND ARE ALSO BEING RETURNED FOR EVAL: ORIGINAL L4 SCREW AND HEAD - 6.5X45MM ((B)(4)) AND PH1 ((B)(4)). ORIGINAL S1 SCREW AND ROD - 6.5X35MM ((B)(4)) AND PH2, 60MM ((B)(4)). NEW S1 SCREW AND ROD - 6.5X35MM ((B)(4)) AND PH2, 50MM ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PH3 HEAD (03-3020-01) PARAMOUNT NKB THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1