BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICAT OUT SHAFT

    MDR report key: 2990345 · Received March 5, 2013

    Report

    Report Number
    8030965-2013-00716
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DIFFICULTLY REMOVING THE IMPLANT HOLDER. ON (B)(6) 2013 THE SURGEON PERFORMED A L4, L5, S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION - TLIF WITH MATRIX DEGEN AND TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR - TPAL. DURING THE PROCEDURE THE SURGEON EXPERIENCED DIFFICULTIES REMOVING THE IMPLANT HOLDER FROM AN 8MM TPAL CAGE IN THE L5, S1 DISC SPACE. THE IMPLANT'S INNER SHAFT BECAME STUCK ON THE IMPLANT AND THE SURGEON STRUGGLED TO DISENGAGE THE IMPLANT FROM THE IMPLANT HOLDER TIP. HE THEN DECIDED TO REMOVE THE OUTER SHAFT SO THAT THE INNER SHAFT WOULD RELEASE. HOWEVER, THE INNER SHAFT STILL WOULD NOT DISENGAGE FROM IMPLANT AND HE STILL COULD NOT REMOVE IT WITH FORCE. EVENTUALLY IT RELEASED AFTER HE USED A PAIR OF FORCEPS TO HELP RELEASE THE TIPS FROM THE IMPLANT. IT WAS SUGGESTED TO THE SURGEON TO REMOVE THE IMPLANT ALL TOGETHER BEFORE HE DISENGAGE THE IMPLANT HOLDER, HOWEVER HE WAS HAPPY WITH HIS CAGE PLACEMENT AND DID NOT WANT TO REMOVE IT. THIS IS OF 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94193 APPLICAT OUT SHAFT LXH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR