BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2632834 · Received June 22, 2012

    Report

    Report Number
    1925223-2012-00046
    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 ON SECOND 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 DIRECTION 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. EVAL SUMMARY: CLAMP STYLE 4. LOT NO. L1. 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 OPENED FAR BEYOND THE DISTANCE NECESSARY FOR PROPER USE. THIS CAUSED PERMANENT DEFORMATION TO THE CLAMP AND SUBSEQUENTLY BREAKAGE OF THE CLAMP.

    Description of Event or Problem · 1

    (B)(4) EMAILED A RETURN REQUEST BECAUSE A CUSTOMER RETURNED A CLAMP TO THEM FOR CREDIT BECAUSE IT IS BROKEN. (B)(4) PROVIDED CUSTOMER CONTACT INFO. ON (B)(4) 2012, SPOKE TO A DENTIST PROFESSOR. I TOLD HIM THAT I CALLED TO GET INFO ON THE INCIDENT INVOLVING THE BROKEN RUBBER DAM. HE SAID THAT IT WAS A STUDENT OF HIS THAT HAD THE CLAMP BREAK. HE SAID THAT I WOULD NEED TO SPEAK TO THIS PERSON. HE SAID HE COULD HAVE THEM CALL ME. I ASKED IF I COULD EMAIL THE QUESTIONS FOR THE DENTIST. HE SAID THAT WAS A GOOD IDEA. HE PROVIDED THE EMAIL ADDRESS. ON (B)(6) 2012, THE DENTIST EMAILED ANSWERS TO THE QUESTIONS. DATE OF INCIDENT- (B)(6) 2012. TOOTH CLAMP USED ON? TOOTH #16. WHEN DURING PROCEDURE CLAMP BROKE? AFTER ABOUT 30-45 MINUTES SINCE THE PLACEMENT OF THE CLAMP. WERE ALL PARTS OF THE CLAMP RETRIEVED? YES. WAS THE CLAMP LIGATED? YES, ANY INJURY? NO. APPROX HOW MANY USES ON THE CLAMP WHEN BROKE? TWO USES, 3 STERILIZATION CYCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC SS 4 REG MOLAR L1

    Patients

    Seq Age Sex Outcome Treatment
    1