BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2799727 · Received October 15, 2012

    Report

    Report Number
    1925223-2012-00194
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    September 19, 2012
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF CAUTION TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. CONCLUSION: DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "CAUTION: MODIFICATION, OVEREXTENDING, BENDING OR EXTENDED USE OF THE CLAMP MAY CAUSE BREAKAGE." COMPLAINT: CLAMP BROKE UPON USE. EVALUATION SUMMARY: THE CLAMP IS DISTORTED FROM ITS ORIGINAL SHAPE. WHEN REASSEMBLED IT WAS OBVIOUSLY PERMANENTLY DEFORMED, UNABLE TO RETURN TO ITS ORIGINAL FORMED SHAPE AND JAW PROXIMITY. CAUSE OF BREAKAGE: MISUSE. CONCLUSION: OVEREXTENSION CAUSED PERMANENT DEFORMATION TO THE CLAMP AND SUBSEQUENTLY BREAKAGE OF THE CLAMP. DUE TO THE AFOREMENTIONED FACT THAT THIS WAS CUSTOMER MISUSE, NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. THE INVESTIGATION IS CLOSED. CAPA MEASURES ARE NOT PROPOSED OR INITIATED.

    Description of Event or Problem · 1

    DEALER EMAILED A COMPLAINT FROM A CUSTOMER THAT, "CLAMP BROKE UPON USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP EEF CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC SS 14A REG MOLAR S1

    Patients

    Seq Age Sex Outcome Treatment
    1