BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL HEAD TAPER 12/14MM Ø 36MM, L

    MDR report key: 22466561 · Received July 10, 2025

    Report

    Report Number
    3012523063-2025-00070
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 9, 2025
    Report Date
    August 14, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    LZO
    PMA / PMN Number
    K163577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, A TRIAL HEAD WAS BROKEN/ TORN. NEITHER THE PRODUCT IN QUESTION, NOR PHOTOS WERE PROVIDED FOR FURTHER INVESTIGATION. THEREFORE, IT CANNOT BE DETERMINED WITHOUT A DOUBT WHERE OR WHAT EXACTLY IS BROKEN. IT IS KNOWN THAT THE INCIDENT HAPPENED INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH IMPACT ON PATIENTS, USERS, OR THIRD PARTIES. IT IS NOT KNOWN HOW EXACTLY THE SURGERY WAS FINISHED (E.G., IF IT WAS FINISHED WITH THE AFFECTED INSTRUMENT OR IF AN ALTERNATIVE PRODUCT WAS USED INSTEAD). BASED ON THE AVAILABLE INFORMATION, NO FAILURE OF THE DESIGN OR DURING THE MANUFACTURING OF THE PRODUCT COULD BE DETERMINED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTION CAN BE REGARDED TO AS A RANDOM FAILURE OF A COMPONENT WITH REGARDS TO THE TRIAL HEAD. A POTENTIAL CAUSE COULD BE AN UNINTENTIONAL USER ERROR, BUT THIS CANNOT BE CONFIRMED OR DENIED DUE TO A LACK OF INFORMATION. THE PRODUCT IS IN USE FOR OVER 5 YEARS. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, A TRIAL HEAD WAS BROKEN/ TORN. THE AFFECTED PRODUCT WAS PROVIDED TO IMPLANTCAST GMBH FOR OPTICAL INVESTIGATION. IT IS KNOWN THAT THE INCIDENT HAPPENED INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH IMPACT ON PATIENTS, USERS, OR THIRD PARTIES. IT IS NOT KNOWN HOW EXACTLY THE SURGERY WAS FINISHED (E.G., IF IT WAS FINISHED WITH THE AFFECTED INSTRUMENT OR IF AN ALTERNATIVE PRODUCT WAS USED INSTEAD). BASED ON THE AVAILABLE INFORMATION, NO FAILURE OF THE DESIGN OR DURING THE MANUFACTURING OF THE PRODUCT COULD BE DETERMINED. THE INSTRUMENT IS MADE OF POLYMER AND MIGHT HAVE BEEN WEAKENED BY TEMPERATURE CHANGES DURING MULTIPLE STERILIZATION CYCLES BEFORE ULTIMATELY BREAKING UNDER INFLUENCE OF HIGH FORCES DURING INTENDED USE. A FURTHER POTENTIAL CAUSE COULD BE AN UNINTENTIONAL USER ERROR, BUT THIS CANNOT BE CONFIRMED OR DENIED DUE TO A LACK OF INFORMATION. THE PRODUCT IS IN USE FOR MORE THAN 5 YEARS. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "BROKEN/ TORN". NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, IT HAD NO ADVERSE IMPACT ON THE PATIENT, THE USER OR THIRD PARTIES. IT IS NOT KNOWN HOW EXACTLY THE SURGERY WAS FINISHED (E.G., IF IT WAS FINISHED WITH THE AFFECTED INSTRUMENT OR IF AN ALTERNATIVE PRODUCT WAS USED INSTEAD).

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "BROKEN/ TORN". NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, IT HAD NO ADVERSE IMPACT ON THE PATIENT, THE USER OR THIRD PARTIES. IT IS NOT KNOWN HOW EXACTLY THE SURGERY WAS FINISHED (E.G., IF IT WAS FINISHED WITH THE AFFECTED INSTRUMENT OR IF AN ALTERNATIVE PRODUCT WAS USED INSTEAD). FOLLOW-UP: IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCTS ON 07/15/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677953 TRIAL HEAD TAPER 12/14MM Ø 36MM, L TRIAL HEAD LZO IMPLANTCAST GMBH 79653610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other