BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCEND

    MDR report key: 164599 · Received April 24, 1998

    Report

    Report Number
    2020467-1998-00003
    Event Type
    Injury
    Date Received
    April 24, 1998
    Date of Event
    March 26, 1998
    Report Date
    March 31, 1998
    Manufacturer
    3M UNITEX
    Product Code
    ECQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST STATED THAT THE ENAMEL DAMAGE DOWN-TO-DENTIN ON TOOTH #10 OCCURRED WHEN CERAMIC BRACKET DEBONDED DURING ARCHWIRE REMOVAL. ORTHODONTIST REPAIRED TOOTH WITH RESIN MATERIAL AND REBONDED ANOTHER BRACKET. ORTHODONTIST STATED THAT THE TOOTH MAY REQUIRE RESTORATION AT THE END OF ORTHODONTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSCEND ORTHODONTIC CERAMIC BRACKET ECQ 3M UNITEX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention BANDS, BUCCAL TUBES, ARCHWIRES. THERAPY DATES:| 8/21/97-12/98.| ORTHODONTIC BONDING ADHESIVE, STAINLESS STEEL