BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3080863 · Received April 26, 2013

    Report

    Report Number
    2530088-2013-10526
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    November 15, 2011
    Report Date
    November 15, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRA OPERATIVELY FOR AN L3-L4 TLIF, THE SURGEON DECIDED TO REPOSITION THE L3 LOCKING. SURGEON BELIEVED THE LOCKING CAP WAS TOO LATERAL. SURGEON ENCOUNTERED DIFFICULTY REMOVING THE LOCKING CAP. A TORQUE LIMITING HANDLE TORQUED OUT BEFORE THE LOCKING CAP COULD BE REMOVED. A STANDARD T-HANDLE WAS USED TO REMOVE THE CAP AND THE TIP OF THE BROKE OFF IN THE LOCKING CAP. THE ROD WAS CUT AND USED TO BACK OUT THE SCREW. THE LOCKING CAP AND SCREW WAS REMOVED. SURGEON IMPLANTED TWO NEW SCREWS, TWO NEW LOCKING CAPS AND A NEW ROD. THE REMOVED HARDWARE (ROD, LOCKING CAP AND SCREW) WAS DISCARDED BY THE HOSPITAL. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    THE PROCEDURE WAS REPORTED TO BE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180988 TI MATRIX LOCKING CAP NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1