BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPLATE L-TI LUMBAR PLATE/IFD/VBR

    MDR report key: 2041244 · Received March 30, 2011

    Report

    Report Number
    3003597504-2011-00001
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 25, 2011
    Manufacturer
    RSB SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K071922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A TWO LEVEL LUMBAR FUSION WAS PERFORMED IN (B)(6) 2010 USING INTERPLATE SCREWS AND PLATES AND SYNTHES PEEK SPACERS. THE PT EXPERIENCED PAIN POST-OPERATIVELY. THE INTERPLATE AND SCREWS WERE REMOVED FROM ONE LEVEL IN (B)(6) 2011. ON X-RAY, THE PLATE APPEARS UNDAMAGED AT THE TIME OF REVISION AND NO SCREW FAILURES WERE REPORTED. THE IMPLANT ASSEMBLY DOES NOT APPEAR LOOSE RADIOGRAPHICALLY. NO IMPLANT MALFUNCTIONS CAN BE IDENTIFIED. THE PLATES WERE BOTH SIGNIFICANTLY SHORTER THAN THE PEEK SPACERS IN THE CEPHALAD - CAUDAL DIRECTION. AN X-RAY TAKEN AT THE TIME OF REVISION SHOWS THE SPACER/PLATE ASSEMBLY AT THE RE-OPERATED LEVEL IS NOT FLUSH WITH THE ANTERIOR SURFACE OF THE SPINE. THE ASSEMBLY AT THE LEVEL THAT WAS NOT REVISED IS NOT AS PROMINENT. THE EXPLANTED DEVICES WERE NOT AVAILABLE FOR ANALYSIS. THERE IS NO EVIDENCE OF IMPLANT MALFUNCTION, BUT AN MDR IS BEING FILED BECAUSE SURGICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPLATE L-TI LUMBAR PLATE/IFD/VBR KWQ, MAX, MQP KWQ RSB SPINE SEE ATTACHED

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention A DEVICE PRODUCED BY A DIFFERENT MFR WAS USED IN| THE ORIGINAL CONSTRUCT.| SYNTHES PEEK SPACER