BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONDABLE LINGUAL CLEAT

    MDR report key: 38945 · Received September 18, 1996

    Report

    Report Number
    2020467-1996-00010
    Event Type
    Injury
    Date Received
    September 18, 1996
    Date of Event
    August 22, 1996
    Report Date
    August 22, 1996
    Manufacturer
    3M UNITEK CORP.
    Product Code
    EJF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    D6, OTHER #: 425 IS A PACKAGING DATE CODE WHICH DENOTES THE DAY THIS PRODUCT WAS PACKAGED. THE PACKAGING DATE CODE FACILITATES TRACEABILITY OF THE PRODUCT. PART NUMBER 709-050.

    Description of Event or Problem · 1

    PERIODONTIST STATED THAT HE SURGICALLY UNCOVERED PT'S IMPACTED UPPER RIGHT CUSPID AND BONDED A LINGUAL CLEAT TO IT; HE ALSO STATED THAT THIS IS ONE OF THE MORE COMMON PROCEDURES WHICH HE PERFORMS. AT A SUBSEQUENT APPOINTMENT, PERIODONTIST NOTED THAT PT HAD REMOVED THE ELASTOMERIC CHAIN ATTACHED TO THE LINGUAL CLEAT AND THAT THE CLEAT HAD SEPARATED FROM ITS BASE, LEAVING ONLY THE BASE OF THE LINGUAL CLEAT ATTACHED TO THE PT'S CUSPID TOOTH. PT'S CUSPID TOOTH HAD SUBSEQUENTLY RECEDED UNDER THE GUM TISSUE, WHICH REQUIRED A SECOND SURGICAL PROCEDURE IN ORDER TO REPLACE THE LINGUAL CLEAT. PERIODONTIST STATED THAT PT'S PROGNOSIS IS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONDABLE LINGUAL CLEAT ORTHODONTIC, ATTACHMENT, LINGUAL EJF 3M UNITEK CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention THERAPY DATES: JANUARY 1993 TO PRESENT.