BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORMCO C-TYPE RELEASE MODULES

    MDR report key: 157710 · Received March 17, 1998

    Report

    Report Number
    2016150-1998-00003
    Event Type
    Malfunction
    Date Received
    March 17, 1998
    Date of Event
    February 1, 1998
    Report Date
    February 13, 1998
    Manufacturer
    ORMCO CORP.
    Product Code
    DZB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS REC'D VIA THE ORTHODONTIST WHO REPORTED THAT THE C-TYPE RELEASE MODULES WOULD NOT EASILY RELEASE FROM THE C-CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORMCO C-TYPE RELEASE MODULES RELEASE MODULES USED WITH ORTHODONTIC HEADGEAR DZB ORMCO CORP. NA 7L & 7M

    Patients

    Seq Age Sex Outcome Treatment
    1 *