BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA

    MDR report key: 3192612 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04137
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 3, 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE COMPLAINED ARTICLE WAS SENT TO THE RESPONSIBLE PRODUCT MANAGER FOR INVESTIGATION; HERE THE FEEDBACK: THE INNER CYLINDER IS BENT IN THE SECTION BY THE T-HANDLE. THIS SHOWS US THAT IT DOES NOT FUNCTION AS INTENDED. THE COMPLAINT CONDITION IS LIKELY A RESULT OF TOO MUCH FORCE WAS APPLIED CROSSWISE TO THE HANDLE. THE PRESENT REMOBILIZATION TOOL WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THIS ARTICLE WAS MANUFACTURED ON FEBRUARY 2012. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4)REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT HAD A DEGENERATIVE SCOLIOSIS. IN XLIF, THE SURGEON FINISHED TO FIX FINALLY T11 ¿ L5 IN THE POSTERIOR. THE OTHER SURGEON MENTIONED A SPONDYLOLISTHESIS, SO THE SURGEON TRIED TO EXTEND THE FIXATION TO S1. THE SURGEON TRIED TO OPEN THE FINAL FIXED HEAD BY THE REMOBILIZING INSTRUMENT, HOWEVER IT DIDN'T WORK WELL AND INNER CYLINDER OF IT DEFORMED AND FINALLY JAMMED AND DID NOT MOVE. THE SURGEON SUCCEEDED TO EXTEND THE ROD TO S1 BY CAREFUL BENDING INTO THE FIXED HEAD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292473 REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA LXH SYNTHES GMBH 7711131

    Patients

    Seq Age Sex Outcome Treatment
    1