BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE TRANSCONNECTOR 31.5MM-34MM FOR 6.0MM RODS

    MDR report key: 2120316 · Received June 2, 2011

    Report

    Report Number
    3003506883-2011-00028
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    NKB
    PMA / PMN Number
    K090605
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    CONSULTANT REPORTED: PATIENT STATUS POST CONSTRUCT IMPLANTATION L3-5 DEVELOPED AN INFECTION. SURGEON REVISED THE PATIENT REMOVING A TI LOW PROFILE TRANSCONNECTOR AT L4 TO PACK THE PATIENT WITH MEDICATION. SURGEON NOTED ALL HARDWARE WAS INTACT AND FUNCTIONING AS INTENDED. PATIENT WAS IMPLANTED ON (B)(4) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LOW PROFILE TRANSCONNECTOR 31.5MM-34MM FOR 6.0MM RODS TI LOW PROFILE TRANSCONNECTOR NKB SYNTHES ELMIRA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR CONSTRUCT