BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRASSELER

    MDR report key: 1729975 · Received June 17, 2010

    Report

    Report Number
    1032227-2010-00011
    Event Type
    Injury
    Date Received
    June 17, 2010
    Report Date
    May 20, 2010
    Manufacturer
    BRASSELER USA
    Product Code
    DZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FROM CUSTOMER FOR EVALUATION. NO LOT NUMBER OF PRODUCT INVOLVED IN THE EVENT WAS AVAILABLE. PRODUCT LOTS AVAILABLE IN INVENTORY WERE TESTED FOR NECK STRENGTH PER ISO 8325:2004. ONLY ONE BUR OF THE 60 SAMPLES TESTED FAILED TO MEET THE CALCULATED FORCE OF 29.49 NEWTONS FOR NECK STRENGTH. THAT BUR BROKE AT 27 NEWTONS. UNABLE TO DETERMINE CAUSE OF BREAKAGE.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AFTER AN EXTRACTION, A PATIENT HAD PAIN AND SWELLING AT THE EXTRACTION SITE. A BUR HEAD WAS REMOVED FROM HEALED EXTRACTION SITE. THE DENTAL OFFICE ADVISED THAT BUR HEAD HAD SNAPPED OFF DURING THE SECTIONING OF A TOOTH DURING THE ORIGINAL EXTRACTION SURGERY. THE OFFICE WAS CONTACTED ON 05/24/2010 AND 05/26/2010 TO OBTAIN ADDITIONAL INFORMATION, INCLUDING PATIENT INFORMATION, BUT NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRASSELER DZA BRASSELER USA H33R.30.016

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention