BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO SMALL OFFSET CONNECTOR

    MDR report key: 1082417 · Received July 18, 2008

    Report

    Report Number
    9617544-2008-00066
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 30, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K070368
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION SURGERY IS ANTICIPATED, BUT HAS NOT BEEN PERFORMED. IN THE EVENT OF REVISION SURGERY, PRODUCT HAS BEEN REQUESTED FOR EVAL, AND IF RECEIVED, WILL CONFIRM LOT NUMBER AND WILL BE SUPPLIED ON A SUPPLEMENTAL. MDR WILL BE UPDATED TO SERIOUS INJURY IF REVISION IS COMPLETED.

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PRIMARY SURGERY WAS PERFORMED. ON (B) (6) 2008, IT WAS FOUND THROUGH THE X-RAY THAT THE CONNECTOR WAS DISASSEMBLED FROM THE SCREW POST. A REVISION SURGERY IS ANTICIPATED, BUT HAS NOT BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIO SMALL OFFSET CONNECTOR IMPLANT NKB STRYKER SPINE BORDEAUX NA 065753

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other