BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPIX-TLIF

    MDR report key: 2822288 · Received May 29, 2012

    Report

    Report Number
    1000432246-2012-00003
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    April 19, 2012
    Report Date
    May 28, 2012
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    MAX
    PMA / PMN Number
    K083798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. INVESTIGATION COULD NOT LEAD TO DEFINE THE PRECISE ROOT CAUSE OF THIS ADVERSE EVENT. CONCLUSION: NO CONCLUSION COULD BE MADE AS INSUFFICIENT INFO HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTS ONE CASE OF BACK OUT OF IMPIX-TLIF CAGE. BACK OUT WAS IDENTIFIED 14 DAYS AFTER SURGERY DURING F/U. REVISION WAS PERFORMED (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPIX-TLIF INTERVERTEBRAL BODY FUSION DEVICE MAX MEDICREA TECHNOLOGIES 10G0393

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization