BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE NT SERIES 29 .167/.04 21MM

    MDR report key: 9923248 · Received April 3, 2020

    Report

    Report Number
    2320721-2020-00041
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Report Date
    March 27, 2020
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    EKS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THE CUSTOMER RE-USES THE FILES WHICH THESE FILES ARE SINGLE USE. AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. PSTA221 LOT 0000065049 DHR INDICATES NON CONFORMANCE NC-002627 WAS ISSUED FOR BLUNT TIPS. PARTS WERE 100% INSPECTED AT 20X MAGNIFICATION. 3 FILES OF PST0321 WERE SCRAPPED FOR BLUNT TIPS. IT IS UNKNOWN IF THIS WAS CONTRIBUTING FACTOR TO THE BREAKAGE IN THIS COMPLAINT. ASSORTMENT DHR INDICATED LOT 0000065455 WAS USED FOR PST0321. REVIEW OF LOT 0000065455 INDICATES NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW. TRACKWISE QUERY INDICATES NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER OR ASSORTMENT LOT NUMBER.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED A PROFILE ROTARY FILE BROKE DURING USE. THE BROKEN PART WAS INCORPORATED INTO THE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384857 PROFILE NT SERIES 29 .167/.04 21MM FILE, PULP CANAL, ENDODONTIC EKS TULSA DENTAL PRODUCTS LLC NA 65049

    Patients

    Seq Age Sex Outcome Treatment
    1