BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI COLLAR FOR 6MM DUAL-OPENINGIMPLANTS

    MDR report key: 2833993 · Received November 15, 2012

    Report

    Report Number
    2530088-2012-00982
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 19, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A REVISION PROCEDURE FOR A PATIENT WHO WAS INITIALLY IMPLANTED WITH A T4 TO ILIUM CONSTRUCT IN (B)(6) 2012. POST OPERATIVELY, THE SURGEON IDENTIFIED THAT THE PATIENT HAD DEVELOPED T3-T4 DISCITIS AND NEUROLOGIC DEFICITS. REVISION SURGERY TOOK PLACE ON (B)(6) 2012. THE T4 - ILIUM CONSTRUCT WAS EXTENDED TO T1. THE 4 SCREWS AT T4 AND T5 WERE FOUND TO BE LOOSE AND WERE REMOVED AND REPLACED WITH LARGER DIAMETER SCREWS. THE SURGEON PLACED SCREWS AT T1, T2, AND T3, CUT BOTH RODS IN-SITU, AND CONNECTED WITH TWO NEW RODS USING EXTENSION CONNECTORS. THE SURGEON ALSO DID AN INTERBODY FUSION AT T3-T4 WITH MTF T-PLIF ALLOGRAFT. THIS IS REPORT #8 OF 14 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI COLLAR FOR 6MM DUAL-OPENINGIMPLANTS TI COLLARFORDUAL-OPENINGIMPLANTS NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention RODS, SCREWS, NUTS