BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER GOLD S2 21MM STER

    MDR report key: 17306640 · Received July 12, 2023

    Report

    Report Number
    8031010-2023-00810
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Report Date
    August 4, 2023
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    UDI-DI
    D716PTGRS2211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY: INVOLVED PRODUCT BROKEN DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1801286). THE THREE UNUSED PROTAPER GOLD SHAPING FILES S2 21MM WERE EVALUATED AND WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 0

    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 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT PROTAPER GOLD S2 21MM STER BROKE DURING USE. THE BROKEN PARTS REMAIN IN THE ROOT CANAL. IT IS REPORTED THAT AT THIS TIME NO TREATMENT BUT FURTHER TREATMENT MAY BE REQUIRED IF PATIENT EXPERIENCES ANY PAIN AT SOME POINT; ROOT TIP RESECTION MIGHT BE NECESSARY IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748259 PROTAPER GOLD S2 21MM STER FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL PTGRS221 1801286 D716PTGRS2211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown