BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAINLESS STEEL DENTAL POST

    MDR report key: 6215791 · Received December 30, 2016

    Report

    Report Number
    2320721-2016-00075
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    February 24, 2017
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    ELR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION IN A SIMILAR DEVICE RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL STAINLESS STEEL POSTS BROKE (EXACT NUMBER UNKNOWN) WHILE CUTTING/REMOVING EXTRA LENGTH PRIOR TO PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865989 STAINLESS STEEL DENTAL POST POST, ROOT CANAL ELR DENTSPLY TULSA DENTAL SPECIALTIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1