BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2564683 · Received April 26, 2012

    Report

    Report Number
    1925223-2012-00009
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Report Date
    April 25, 2012
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    GENERALLY BROKEN CLAMPS HAVE NOT BEEN REPORT BUT AS THE DENTIST ALLEGES THAT, "THE REMNANT LITERALLY SHOOT ACROSS THE ROOM WHICH IS DANGEROUS." IT IS FOR THIS REASON THAT IT IS RECOMMENDED THAT THE INCIDENCES BE REPORTED. THE DENTIST HAS STATED THAT NO ONE WAS INJURED DURING THE INCIDENCES. ACTUAL DEVICE WAS DISPOSED OF BY OFFICE. BATCH NUMBER IS UNK. THE DIRECTIONS FOR USE STATES THAT THE RUBBER DAM CLAMP SHOULD BE LIGATED TO THE FRAME AND THE RUBBER DAM ASSEMBLY PLACED BEFORE THE CLAMP IS PLACED ON THE TOOTH. THIS WOULD PRECLUDE CHOKING AND ASPIRATING HAZARDS FROM DEVICE BREAKAGE. ALSO, DEVICE BREAKAGE IS ADDRESS IN THE DIRECTIONS FOR USE AS THIS CAN OCCUR DUE TO MODIFICATION, OVEREXTENDING, BENDING OR EXTENDED USE.

    Description of Event or Problem · 1

    THIS IS THE THIRD OF 4 COMPLAINTS FROM ONE OFFICE ON 4 SEPARATE EVENTS FOR 4 DIFFERENT CLAMPS. ON (B)(6) 2012 WE WERE INFORMED THAT AN OFFICE WAS EXPERIENCING 12A CLAMPS BREAKING. THE DENTIST IS ANGRY "BECAUSE IT'S A TERRIBLE THING TO HAPPEN IN THE MIDDLE OF TREATMENT. PTS CONFUSE THE SOUND FOR THEIR TOOTH BREAKING PLUS THE REMNANTS LITERALLY SHOOT ACROSS THE ROOM WHICH IS DANGEROUS." IN SEVEN YRS IT'S HAPPENED TO HIM ONE, NOW IT'S HAPPENED FOUR TIMES IN FOUR MONTHS. THE ASSISTANT SAID THAT THEY HAVE HAD A 12A CLAMP BREAK ABOUT 1 EVERY MONTH. THEY ARE GETTING ABOUT 6 USES PER CLAMP. THEY ARE ONLY EXPERIENCING THIS WITH THE 12A CLAMPS. HE SAID THEY OPENED THIS OFFICE (B)(6) 2012 AND THAT THEY USE IVORY CLAMPS. HE SAID NONE OF THE OTHER CLAMPS ARE BREAKING. HE SAID AT FIRST IT WAS THE MATTE FINISH SO THEY SWITCHED TO STAINLESS FINISH. HE SAID HE DOES NOT REMEMBER THE FIRST PTS IT HAPPENED TO AND COULD NOT LOOK THEM UP. HE SAID THAT THE LATEST CLAMP WAS ON A FEMALE PT (B)(6). HE SAID THEY WERE DOING A ROOT CANAL ON (B)(6) 2012 AND IT BROKE AND SHOT THE PIECES ACROSS THE ROOM. HE SAID THAT EVERY TIME THIS HAPPENS, IT IS VERY UPSETTING TO THE PT AND THEY HAVE TO EXPLAIN WHAT HAS HAPPENED. I ASKED WHERE THEY USE THE CLAMP. HE SAID ON THE UR AND LL MOLARS. HE SAID IT DOES NOT HAPPEN WHEN THEY ARE PLACING THE CLAMP, BUT DURING THE PROCEDURE IT WILL SUDDENLY BREAK AND IT IS DANGEROUS. HE SAID THAT BOTH PIECES WILL SHOOT OUT LIKE PROJECTILES AND IT IS VERY FRIGHTENING. HE ASKED WHAT CAUSED IT. I TOLD HIM THAT I WANTED TO PICK UP THE CLAMP SO THAT WE COULD START AN INVESTIGATION. I TOLD HIM THAT I WOULD BE STAYING IN CONTACT WITH HIM. HE SAID HE WOULD APPRECIATE THAT. DR. (B)(6) CAME TO THE PHONE AND HE EXPLAINED THAT THIS IS VERY UPSETTING. HE SAID HE HAS BEEN PRACTICING FOR 10 YRS AND THIS HAS ONLY OCCURRED 1 TIME. HE SAID THAT NOW HE HAS HAD IT HAPPEN 4 TIMES IN 4 MONTHS. HE SAID THAT HE IS VERY CONCERNED AND THAT THE BREAKAGE IS A HAZARD TO HIS PTS AND STAFF. I APOLOGIZED AND TOLD HIM WE TAKE THIS VERY SERIOUS AND THAT AN INVESTIGATION WOULD HAPPEN. HE SAID HE WAS GLAD TO HEAR THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC MATTE SS 12 A

    Patients

    Seq Age Sex Outcome Treatment
    1