BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL SPACER 12MM X 32MM 9MM HEIGHT

    MDR report key: 2901252 · Received January 8, 2013

    Report

    Report Number
    8030965-2013-00072
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    K100089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    DURING A PROCEDURE FOR AN L5-S1 INTERBODY SPACER AND FUSION PROCEDURE, THE IMPLANT HOLDER WOULD NOT DISENGAGE FROM THE TPAL SPACER IMPLANT. THE HANDLE FROM THE DEVICE WAS REMOVED, HOWEVER, THE BLACK INNER SHAFT WOULD NOT DISENGAGE FROM THE IMPLANT. AFTER THE SURGEON STRUGGLED WITH THE DEVICE, THE BLACK INNER SHAFT BROKE OFF, LEAVING ONE SIDE OF THE MOUTH EMBEDDED IN THE TPAL SPACER IMPLANT. THE SURGEON PRIED AND DRILLED AROUND THE BROKEN SHAFT PIECE TO REMOVE IT FROM THE SURGICAL SITE. THIS PROCEDURE WAS PROLONGED AN ADDITIONAL 45 MINUTES. THE TPAL SPACER IMPLANT WAS LEFT IMPLANTED AND THE BROKEN IMPLANT HOLDER INNER SHAFT WAS REMOVED. THIS IS # 2 OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9581 T-PAL SPACER 12MM X 32MM 9MM HEIGHT T-PAL SPACER MAX SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention TPAL INNER SHAFT