BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG HANDLE WEINGART PLIERS

    MDR report key: 8625181 · Received May 20, 2019

    Report

    Report Number
    2016150-2019-00012
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    March 29, 2019
    Report Date
    May 20, 2019
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EJY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, DURING A ROUTINE ACTIVATION APPOINTMENT WHILE CRIMPING THE STOPS ON A MAXILLARY 19X25TMA ARCHWIRE, THE BEAK OF AN ORMCO WEINGHART PLIER BROKE INTRA-ORALLY. THIS RESULTED IN A SLIP AND FRACTURE OF THE MESIAL INCISAL CORNER OF THE PATIENT'S #21 AS WELL AS A SMALL LACERATION OF THE ATTACHED GINGIVAL APICAL TO THE #21 AND A SMALL CUT IN THE MAXILLARY LIP NEAR THE VERMILLION BORDER. THE PATIENT REQUIRED A COMPOSITE RESTORATION ON THE #21 WHICH WAS COMPLETED BY THE FAMILY DENTIST 48 HOURS LATER. FUTURE RESTORATIVE NEEDS FOR THE #21 ARE UNDETERMINED AT THIS TIME, HOWEVER, IT IS LIKELY THAT THE PATIENT WILL REQUIRE FUTURE PROSTHODONTIC TREATMENT WITH EITHER A PORCELAIN VENEER OR A FULL COVERAGE CROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418178 LONG HANDLE WEINGART PLIERS EYJ EJY ORMCO CORPORATION C18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention