BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA MESH 122X122XX

    MDR report key: 2587143 · Received May 21, 2012

    Report

    Report Number
    8010177-2012-00129
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 25, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K113109
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE MESH WAS REJECTED BY THE PATIENT. ABOUT 8 WEEKS POST OPP THERE WERE SPOTS OF CONTINUOUS SCABBING WITHOUT ANY HEALING. WHEN THEY EXPLORED MORE, 1CM X 2CM WITH TWO HOLES (NO SCREWS) OF THE DELTA MESH CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA MESH 122X122XX NA HRS STRYKER OSTEOSYNTHESIS FREIBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK