BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2870417 · Received November 12, 2012

    Report

    Report Number
    1925223-2012-00201
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Report Date
    October 17, 2011
    Manufacturer
    HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE¿RE REPORTING IT OUT OF CAUTION TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. NARRATIVE FOR 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: THE CLAMP IS DISTORTED FROM ITS ORIGINAL SHAPE. WHEN REASSEMBLED IT WAS OBVIOUSLY PERMANENTLY DEFORMED, VASTLY UNABLE TO RETURN TO ITS ORIGINAL FORMED SHAPE AND JAW PROXIMITY. CAUSE OF BREAKAGE: MISUSE. CONCLUSION: OVER-EXTENSION OF THE CLAMP CAUSED PERMANENT DEFORMATION TO THE CLAMP AND SUBSEQUENTLY BREAKAGE OF THE CLAMP. THE CLAMP WAS REPORTED TO HAVE BEEN USED ON A MOLAR. THIS CLAMP IS A BICUSPID CLAMP. USAGE OF THIS CLAMP ON MOLARS WILL CAUSE OVER-EXTENSION AS THE CLAMP IS ONLY INDICATED FOR USE ON BICUSPID AND NOT MOLARS. CLAMP OVER-EXTENSION IS CONSIDERED MISUSE. MISUSE OF THIS NATURE WILL CAUSE THE CLAMP TO BE OVER-EXTENDED FOR PLACEMENT AND TO REMAIN OVER-EXTENDED WHILE CLAMPED ONTO THE TOOTH. THE USER USED THIS CLAMP ON AN UNAPPROVED TOOTH. DUE TO THE AFOREMENTIONED FACT THAT THIS WAS CUSTOMER MISUSE, NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. THE INVESTIGATION IS CLOSED. CAPA MEASURES ARE NOT PROPOSED OR INITIATED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    ON (B)(6) 2012 HKG REP SENT AN E-MAIL TO HKNA: TODAY WE RECEIVED ONE BROKEN IVORY CLAMP 2 FROM (B)(6). THE CUSTOMER COMPLAINS THAT THE CLAMP IS BROKEN AFTER USING TWO TIMES. THE CLAMP WAS PURCHASED IN (B)(6) 2012 WITH HKG. ON (B)(6) 2012 HKG REP EMAILED THE FOLLOWING USAGE INFORMATION: TODAY I¿VE HAD A PHONE CONFERENCE WITH THE DENTAL DEALER INFORMING US ABOUT YOUR QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP EEF CLAMP, RUBBER DAM EEF HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION SS 2 REG BICUSP O1

    Patients

    Seq Age Sex Outcome Treatment
    1