BEUDAMED
    FDA Adverse Event Other Summary report: N

    IVORY CLAMP

    MDR report key: 2623701 · Received June 11, 2012

    Report

    Report Number
    1925223-2012-00037
    Event Type
    Other
    Date Received
    June 11, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 15, 2012
    Manufacturer
    HERAEUS KULZER, LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DEVICE WAS WELL BEYOND ITS USE LIFE, WE¿RE REPORTING IT OUT OF AN ABUNDANCE OF CAUTION TO BE COMPLIANT WITH 21 CFR PART 803. THE USE OF LIFE OF THE CLAMP IS ONE YEAR. THIS INCIDENT DID NOT RESULT IN ANY PT INJURY. VISUAL INSPECTION SHOWED THAT THE CLAMP WAS BROKEN, BUT THE LOT CODE WAS 3I WHICH WAS MANUFACTURED 02/1/2003. THE LABELING WAS EVALUATED AND IT STATES, ¿CAUTION: MODIFICATION, OVER EXTENDING, BENDING, AND EXTENDED USE LIFE MAY CAUSE BREAKAGE.¿ THE RESULTS SHOWED THAT THE CLAMP HAD EXCEEDED THE 1 YEAR USE LIFE. IT WAS CONCLUDED THAT THE CLAMP USE AT THIS POINT IS NOT SUPPORTED.

    Description of Event or Problem · 1

    (B)(4) 2012, HERAEUS SALES REP. EMAILED REQUESTING THAT THE OFFICE BE CONTACTED ABOUT A BROKEN CLAMP. SPOKE TO OFFICE ASSISTANT. SHE SAID THAT THEY WERE PREPARING TO PLACE THE RUBBER DAM ASSEMBLY INTO TOOTH #26 AND THE CLAMP BROKE AS THEY TRIED TO PLACE IT. HALF OF THE CLAMP WENT DOWN THE PT¿S THROAT AND THE PT STARTING COUGHING REAL HARD AND COUGHED IT UP. SHE SAID THAT SHE AND DENTIST WERE QUITE STARTLED, BUT THAT THE PT WAS FINE AND WANTED TO PROCEED WITH THE TREATMENT. THEY PLACE THE RUBBER DAM ASSEMBLY ALL AT ONCE, BUT DID NOT HAVE THE CLAMP LIGATED TO THE FRAME. SHE SAID THE CLAMP WAS ATTACHED TO THE RUBBER DAM. I TOLD HER THAT THE CLAMP WAS MADE IN 2003 AND NEARLY 10 YEARS OLD. SHE ASKED HOW THEY ARE TO KNOW HOW OLD A CLAMP IS AND WANTED TO KNOW THE LIFE EXPECTANCY. I TOLD HER THAT WE WARRANTY FOR 1 YEAR OF USE. I TOLD HER THAT I STILL WANT THE CLAMP RETURNED FOR EVAL AND WOULD SEND HER A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER, LLC SS 14 REG MOLAR 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention