BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS

    MDR report key: 1900343 · Received October 26, 2010

    Report

    Report Number
    1649384-2010-00171
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    PMA / PMN Number
    K073202
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE IMPLANT ASSOCIATED WITH THE REPORTED EVENT HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE IMPLANT IS RECEIVED AND THE INVESTIGATION OF PRODUCT PROBLEM IS COMPLETED.

    Description of Event or Problem · 1

    THE IMPLANT BROKE DURING THE EXECUTION OF THE SURGICAL TECHNIQUE. THE SURGEON REMOVED THE BROKEN IMPLANT AND USED ANOTHER IMPLANT TO FINISH THE SURGERY WITHOUT COMPLICATION, SERIOUS INJURY OR PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARDIS PEEK IMPLANT MAX ZIMMER SPINE NA 2222791

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR