BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SIMPLEX B BONE CEMENT

    MDR report key: 47003 · Received October 30, 1996

    Report

    Report Number
    9610726-1996-00033
    Event Type
    Malfunction
    Date Received
    October 30, 1996
    Report Date
    October 29, 1996
    Manufacturer
    HOWMEDICA INC.
    Product Code
    LOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: THE EVALUATION RESULTS INDICATED NO ABNORMALITIES IN THE CEMENT. ALL TEST RESULTS WERE SATISFACTORILY AND IN ACCORDANCE WITH THE REGISTERED SPEC FOR THE PRODUCT.

    Description of Event or Problem · 1

    THE CEMENT DID NOT MIX TO THE PROPER CONSISTENCY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SIMPLEX B BONE CEMENT BONE CEMENT LOD HOWMEDICA INC. NA 0688D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 6204-2-001- ENHANCEMENT MIXING SYRINGE| 6204-1-200- ENHANCEMENT CEMENT MIXER