BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - CE TOBRA FD 10-PK

    MDR report key: 1905657 · Received November 12, 2010

    Report

    Report Number
    9610726-2010-00427
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 29, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Removal / Correction Number
    N
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "CEMENT HARDENING FASTER THAN USUAL WAS THE REPORT FROM THE SURGEON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - CE TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA THR048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other