BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PH2 ASSY; 30MM (03-0300-01)

    MDR report key: 2093561 · Received April 6, 2011

    Report

    Report Number
    3008657535-2011-00009
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 6, 2011
    Manufacturer
    INTEGRA, MEDINA
    Product Code
    NKB
    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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SPINAL SURGERY PROCEDURE FOR A VERTEBRA FUSION AT LEVEL L4-5; WHILE THE SURGEON WAS INSERTING THE LAST SCREW WITH A ROD ATTACHED, THE ROD DISENGAGED, OR SLIPPED, FROM THE SHAFT OF THE SCREW. BECAUSE THIS ALLOWS THE HEAD OF THE SCREW TO SPIN, THE TULIP (EXTENSION SCREW ASSEMBLY) STARTED TO DISENGAGE FROM THE SHAFT. THE SCREW WAS 7.5 MM DIAMETER WITH A 30MM ROD. THE SCREW HOLE HAD BEEN TAPPED. THE SURGEON REMOVED THIS SCREW AND ROD ASSEMBLY AND REPLACED IT WITH ANOTHER OF THE SAME DIMENSIONS AND COMPLETED THE CASE. THE SCREW REVISION ADDED ABOUT TEN MINUTES TO THE LENGTH OF THE PROCEDURE. THERE WERE NO OTHER COMPLICATIONS TO THE PATIENT OR PROCEDURE REPORTED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PH2 ASSY; 30MM (03-0300-01) PARAMOUNT NKB INTEGRA, MEDINA

    Patients

    Seq Age Sex Outcome Treatment
    1