BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTILITY PLIER (WEINGART STYLE)

    MDR report key: 2887392 · Received December 19, 2012

    Report

    Report Number
    2086211-2012-00001
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 26, 2012
    Manufacturer
    DENTSPLY GAC
    Product Code
    JEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVALUATION OF THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE THIS ISSUE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE DEVICE MALFUNCTIONED AND THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION. DURING THE INVESTIGATION IT WAS FOUND THAT THE DOCTOR WAS USING UTILITY PLIERS AS A CRIMPABLE STOP, WHICH IS NOT THE INTENDED USE OF THIS DEVICE, AND LIKELY THE CAUSE FOR THE BEAK BREAKAGE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT THE TIP OF A UTILITY PLIER (WEINGART STYLE) SEPARATED INSIDE OF A PATIENT'S MOUTH AND CHIPPED THEIR TOOTH. AS A RESULT A COMPOSITE CROWN WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTILITY PLIER (WEINGART STYLE) JEX DENTSPLY GAC 07-06-1

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention CRIMPABLE STOP