BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA-JR TOFFLEMIRE TYPE RET

    MDR report key: 24911575 · Received April 17, 2026

    Report

    Report Number
    3014334038-2026-00030
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Report Date
    May 26, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JEP
    UDI-DI
    10381780414018
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE CA-JR TOFFLEMIRE TYPE RET (72-30) MATRIX BAND FELL OUT OF THE RETAINER WHILE IN THE PATIENT'S MOUTH. THERE WAS A SMALL DELAY IN TREATMENT OF APPROXIMATELY 30 MINUTES; HOWEVER, NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322609 CA-JR TOFFLEMIRE TYPE RET INSTRUMENTS - DENTAL JEP INTEGRA LIFESCIENCES MANSFIELD CV2408B 10381780414018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown