BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOST

    MDR report key: 6215787 · Received December 30, 2016

    Report

    Report Number
    2320721-2016-00072
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    November 29, 2016
    Report Date
    March 24, 2017
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    ELR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE LOT NUMBER REPORTED WAS FOUND TO BE INVALID. THEREFORE, RETAINED-PRODUCT TESTING AND/OR DHR REVIEW IS NOT POSSIBLE.

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION 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. THIS REPORT IS FOR THE SECOND DEVICE. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PROPOST POSTS BROKE DURING PLACEMENT IN ONE PATIENT. BOTH POSTS WERE RETRIEVED AND THE DENTIST WAS ABLE TO SEAT ANOTHER POST AND COMPLETE THE RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865256 PROPOST POST, ROOT CANAL ELR DENTSPLY TULSA DENTAL SPECIALTIES NA 83012216

    Patients

    Seq Age Sex Outcome Treatment
    1