BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2621683 · Received June 12, 2012

    Report

    Report Number
    1925223-2012-00038
    Event Type
    Malfunction
    Date Received
    June 12, 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 Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE CLAMP BREAKAGE ALLEGEDLY OCCURRING ON WITHIN FIRST MONTH OF USE 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." THE DENTIST HAS STATED THAT NO ONE WAS INJURED DURING THE INCIDENCES.

    Description of Event or Problem · 1

    (B)(4) 2012, (B)(4) HAS A CLAMP THAT WAS RETURNED FOR CREDIT BECAUSE IT BROKE ON THE FIRST USE. (B)(4) 2012 CALLED THE OFFICE. THE VOICE MESSAGE SAID THAT THEY WOULD BE CLOSED UNTIL (B)(4). I LEFT A MESSAGE THAT I CALLED CONCERNING THE CLAMP THAT BROKE ON FIRST USE AND ASKED THAT THEY CALL BACK. I LEFT MY CONTACT INFORMATION. (B)(4) 2012 SPOKE TO (B)(6). SHE SAID THAT THEY HAD TWO CLAMPS BREAK IN (B)(6) 2011. SHE SAID THAT (B)(6) WAS THE ONE USING THEM AND SHE NO LONGER WORKS AT THIS PRACTICE. SHE SAID THAT ON (B)(6) 2011 SHE RECEIVED AN ORDER OF 10 W4 CLAMPS. SHE SAID THAT THEY HAD 2 OF THE CLAMPS BREAK. SHE SAID THAT THE FIRST ONE BROKE AND THEY THREW IT AWAY. SHE SAID THEN THE SECOND ONE BROKE AND THEY DECIDED TO GIVE IT TO THE SCHEIN REP (B)(4) NEXT TIME HE CAME IN. SHE DID NOT REMEMBER WHEN THE FIRST ONE BROKE, HOWEVER THE SECOND ONE BROKE FOR (B)(6) ON (B)(6) 2011. SHE SAID THAT (B)(6) WOULD OFTEN PLACE THE CLAMP ON THE TOOTH THEN PULLS THE RUBBER DAM OVER THE CLAMP. SHE SAID THAT THE CLAMP BROKE WHILE SHE WAS PLACING THE CLAMP ONTO THE TOOTH. SHE SAID THAT BOTH PIECES WERE RETRIEVED AND THE PATIENTS WERE NOT INJURED. SHE SAID THAT THEY HAVE NOT HAD ANY TROUBLE SINCE THOSE 2 BROKE. SHE STATED ALL THE OTHER CLAMPS HAVE NOT BROKEN. SHE SAID THAT THEY USE THESE CLAMPS ON 6 AND 7S. I ASKED IF SHE WAS REFERRING TO MOLARS. SHE SAID THAT THEY USE THE SYSTEM WERE THE CENTRALS ARE #1 AND THE 3RD MOLARS ARE #8. I ASKED IF SHE NEEDED ANYTHING AND SHE SAID THAT SHE WAS NEVER CREDITED FOR THE CLAMPS. SHE ASKED IF WE COULD REPLACE THE CLAMPS. I TOLD HER I WOULD SEND HER 2 CLAMPS TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC SS W4 WNGLSS MOLAR

    Patients

    Seq Age Sex Outcome Treatment
    1