BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PRIM BEAD PA SZE2 BP

    MDR report key: 1062277 · Received June 17, 2008

    Report

    Report Number
    9610726-2008-00034
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    MBH
    PMA / PMN Number
    051380
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REPRESENTATIVE WAS PRESENT DURING SURGERY. HE REPORTED THAT HE OBSERVED THAT THERE WAS AN AREA (ALMOST 3X3MM) ON THE DEVICE WHICH WAS NOT RECOVERED BY PERIAPATITE. THE SURGEON IMPLANTED THE DEVICE. NO CONSEQUENCE FOR THE PT AND NO DELAY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PRIM BEAD PA SZE2 BP IMPLANT MBH STRYKER ORTHOPAEDICS NA SFTND

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other