BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 2902450 · Received January 8, 2013

    Report

    Report Number
    2530088-2013-00037
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    June 13, 2012
    Report Date
    June 13, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A PLIF PROCEDURE AT LEVELS L3-S1. DURING THIS PROCEDURE, WHICH OCCURRED ON (B)(6) 2012, FOUR OF THE TWELVE LOCKING CAPS WOULD NOT ENGAGE THE SCREWS ON INSERTION. THE THREADS ON THE CAPS BECAME CROSS THREADED, AND COULD NOT BE USED. SURGEON REPLACED THESE FOUR LOCKING CAPS WITH FOUR NEW ONES, WHICH SEATED CORRECTLY. THERE WAS NO PROBLEM WITH SEATING OR TIGHTENING ANY OF THE OTHER HARDWARE. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. SURGERY WAS EXTENDED BY APPROXIMATELY 30 MINUTES. THIS IS 4 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9363 TI MATRIX LOCKING CAP LOCKING CAP NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SCREWS