BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE 20MM

    MDR report key: 1881270 · Received October 7, 2010

    Report

    Report Number
    1530901-2010-00120
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 17, 2009
    Report Date
    October 7, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS 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. THE INVESTIGATION DETERMINED THAT THE PLATE LOT NUMBER WAS W10336, AND THE SCREW LOT NUMBER WAS W10399. THIS WAS A NEW STYLE PLATE AND SCREW, AND THE SECOND COMPLAINT CONCERNING THIS VERSION OF THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ANOMALIES. FAILURE OF THE LOCKING MECHANISM WAS ADDRESSED IN THE FAILURE MODES AND EFFECTS ANALYSIS (FMEA) OF THE DEVICE DESIGN DOSSIER. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS 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 A MANTA RAY ANTERIOR CERVICAL PLATE, THE SURGEON INSERTED THE SCREW INTO THE HOLE AT THE TOP RIGHT OF THE PLATE. THE RETAINING ARM SEEMED TO LOCK THE SCREW, HOWEVER, DURING PLACEMENT OF THE THREE OTHER SCREWS, IT BECAME DISENGAGED AND WOULD NOT REENGAGE DURING FINAL TIGHTENING. THE SCREW WAS REMOVED, AND THE SURGEON OPTED NOT TO REPLACE IT. THERE WAS NO ADVERSE OUTCOME FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE 20MM MANTA RAY KWQ THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.