BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, UNKNOWN

    MDR report key: 1881290 · Received October 7, 2010

    Report

    Report Number
    1530901-2010-00118
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    August 18, 2009
    Report Date
    October 7, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF INTEGRA'S TWO YEAR RETROSPECTIVE REVIEW, WHICH IS STILL ONGOING, INTEGRA CONCLUDED THAT THIS MEDICAL DEVICE REPORT SHOULD HAVE BEEN SUBMITTED AT THE TIME THAT THE COMPLAINT WAS RECEIVED. NO PRODUCT WAS RETURNED FOR EVALUATION. THE PLATE WAS USED TO COMPLETE THE SURGERY. THIS WAS THE FIRST COMPLAINT TO BE REPORTED WITH THE THICKER VERSION OF THE MANTA RAY PLATES. THE ISSUE OF LOCKING MECHANISM FAILURE WAS ADDRESSED TO THE FAILURE MODES AND EFFECTS ANALYSIS (FMEA) FOR THE DEVICE DESIGN DOSSIER. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE RPTR STATED THAT DURING A SPINAL SURGERY PROCEDURE USING THE MANTA RAY ANTERIOR CERVICAL PLATE, THE SURGEON WAS UNABLE TO LOCK A FIXED SCREW USING THE INTEGRAL RETAINING ARM. THE SITE WAS AT THE TOP RIGHT OF THE PLATE. THE SURGEON REMOVED THE FIXED SCREW AND REPLACED IT WITH A VARIABLE SCREW WHICH FUNCTIONED PROPERLY. THERE WAS NO ADVERSE OUTCOME FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW, UNKNOWN MANTA RAY KWQ THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1