BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TI MIN INVASIVE CURVED ROD 100MM RADIUS/35MM

    MDR report key: 2820222 · Received November 6, 2012

    Report

    Report Number
    8030965-2012-01191
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K093668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    PATIENT HAD A LEFT L5-S1 MINIMALLY INVASIVE LUMBAR FUSION PROCEDURE ON (B)(6) 2012. FOLLOW UP X-RAYS TAKEN (B)(6) 2012 REVEALED THAT THE LEFT L5 LOCKING CAP WAS LOOSE. SURGEON REVISED PATIENT BY TIGHTENING UP LEFT L5 LOOSE LOCKING CAP. DURING THE REVISION PROCEDURE, SURGEON NOTED THAT THE RIGHT S1 LOCKING CAP APPEARED TO BE LOOSE. AFTER REVIEWING THE X-RAYS, THE SURGEON COULD NOT DEFINITIVELY CONFIRM THE LOOSE S1 CAP. THE SURGEON REMOVED 4 LOCKING CAPS AND 2 RODS AND REPLACED WITH 2 SCREWS AT L4, 2 NEW RODS, AND 6 NEW LOCKING CAPS. BOTH SYSTEMS USED IN THE ORIGINAL IMPLANT AND REVISION WERE MATRIX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FACILITY DISCARDED THE REMOVED HARDWARE. THIS IS THE # 6 OF 6 OF REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM TI MIN INVASIVE CURVED ROD 100MM RADIUS/35MM MIN INVASIVE CURVED ROD NKB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS, LOCKING CAPS, RODS