BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3375991 · Received September 30, 2013

    Report

    Report Number
    2530088-2013-01190
    Event Type
    Injury
    Date Received
    September 30, 2013
    Date of Event
    December 14, 2012
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES: MNH, MNI, KWO, KWP. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. FURTHER REVIEW OF THE COMPLAINT WAS REQUIRED AND THE FOLLOWING PARTS WERE ADDED TO THE COMPLAINT THAT WERE NOT ORIGINALLY CAPTURED ON INITIAL FILING DATE (B)(4) 2013: ON (B)(6) 2013 - 3 OF 3 - TI MATRIX LOCKING CAP; PART NUMBER 04.632.000 WAS ADDED; LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH THE MATRIX MIS SYSTEM FOR POSTERIOR LUMBAR INTERBODY FUSION (PLIF) ON (B)(6) 2012. ALL POLYAXIAL SCREWHEADS WERE REMOVED AND REDUCTION HEADS WERE PLACED ON THE SCREWS PRIOR TO IMPLANTATION. ON AN UNKNOWN DATE, PATIENT PRESENTS TO SURGEON FOR POST-OPERATIVE FOLLOWUP COMPLAINING OF PAIN. EXAMINATION AND X-RAY REVEAL THE RIGHT SIDE OF THE CONSTRUCT SHOWS THE L4 LOCKING CAP TO BE FREE FLOATING OUT OF THE POLYAXIAL HEAD, AND THE L5 AND S1 CAPS TO BE LOOSE BUT STILL ENGAGED IN THE POLYAXIAL HEADS OF THE SCREWS. THE ROD ITSELF HAS SLID DOWN AND PASSED THROUGH THE HEADS OF THE L4 AND L5 SCREWS AND IS ALMOST FREE FLOATING OVER THE SACRUM. ON AN UNKNOWN DATE PATIENT RETURNED TO OR FOR SURGICAL INTERVENTION. SURGEON REPOSITIONED ROD AND REPOSITIONED L4 LOCKING CAP, AND RETIGHTENED L4, L5, AND S1 LOCKING CAPS. THIS IS REPORT 5 OF 5 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491263 TI MATRIX LOCKING CAP NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention