BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2632823 · Received June 22, 2012

    Report

    Report Number
    1925223-2012-00047
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Report Date
    May 29, 2012
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE CLAMP BREAKAGE ALLEGEDLY OCCURRING DURING USAGE LIFE, THE CLAMP MALFUNCTION WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 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." EVAL SUMMARY: CLAMP STYLE W5, LOT NO. A1. ONE CLAMP WAS RETURNED BROKEN. CAUSE OF BREAKAGE: CUSTOMER MISUSE. THE CLAMP IS DISTORTED FROM ITS ORIGINAL SHAPE AND IT IS EVIDENT THAT THE CLAMP WAS CONTORTED (THE PITCH OF THE JAWS OF THE CLAMPS WERE ADJUSTED AT OPPOSITE ANGLES). THIS ADJUSTMENT CAUSED PERMANENT DEFORMATION TO THE CLAMP AND SUBSEQUENTLY BREAKAGE OF THE CLAMP.

    Description of Event or Problem · 1

    ON (B)(6) 2012, SCHEIN (B)(4) EMAILED A RETURN REQUEST. THE CUSTOMER RETURNED A CLAMP FOR CREDIT BECAUSE IT IS BROKEN. THE DENTAL OFFICE WAS CONTACTED TO DISCUSS DETAILS OF THE CLAMP BREAKAGE. A MESSAGE WAS LEFT ON THE ANSWERING MACHINE TO CALL BACK. ON (B)(4) 2012, LEFT MESSAGE ON THE ANSWERING MACHINE TO CALL BACK ABOUT THE RUBBER DAM CLAMP THAT BROKE THAT THEY RETURNED TO HENRY SCHEIN. ON (B)(4) 2012, LEFT THIRD VOICE MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC SS W5 WNGLSS MOLAR A1

    Patients

    Seq Age Sex Outcome Treatment
    1