BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP

    MDR report key: 22536456 · Received July 17, 2025

    Report

    Report Number
    3009962553-2025-00001
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 17, 2025
    Manufacturer
    CLARIANCE SAS
    Product Code
    NKG
    PMA / PMN Number
    K120469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025 - THE POLYAXIAL SCREW DISASSEMBLED INTRAOPERATIVELY WHILE BEING MANEUVERED, RESULTING IN AN UNANTICIPATED INTERRUPTION OF THE SURGICAL PROCEDURE. WHILE THE DISASSEMBLY WAS IDENTIFIED BY THE SURGEON AND THE COMPONENT WAS REMOVED AND REPLACED, THIS EVENT REQUIRED ADDITIONAL SURGICAL INTERVENTION. ALTHOUGH THE PROCEDURE WAS COMPLETED WITHOUT IMMEDIATE HARM TO THE PATIENT, THE EVENT CONSTITUTES A MALFUNCTION OF A MEDICAL DEVICE THAT, IF IT WERE TO RECUR, COULD LEAD TO SERIOUS INJURY OR REQUIRE SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO A BODY STRUCTURE. THIS EVENT IS REPORTABLE AS A MALFUNCTION.

    Additional Manufacturer Narrative · 0

    (B)(6) 2025 - THE POLYAXIAL SCREW DISASSEMBLED INTRAOPERATIVELY WHILE BEING MANEUVERED, RESULTING IN AN UNANTICIPATED INTERRUPTION OF THE SURGICAL PROCEDURE. WHILE THE DISASSEMBLY WAS IDENTIFIED BY THE SURGEON AND THE COMPONENT WAS REMOVED AND REPLACED, THIS EVENT REQUIRED ADDITIONAL SURGICAL INTERVENTION. ALTHOUGH THE PROCEDURE WAS COMPLETED WITHOUT IMMEDIATE HARM TO THE PATIENT, THE EVENT CONSTITUTES A MALFUNCTION OF A MEDICAL DEVICE THAT, IF IT WERE TO RECUR, COULD LEAD TO SERIOUS INJURY OR REQUIRE SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO A BODY STRUCTURE. THIS EVENT IS REPORTABLE AS A MALFUNCTION. 10/16/2025 - ANALYSIS REPORT CONCLUSION: THE DETAILED CONTEXT OF THE SURGERY WAS NOT AVAILABLE SO IT WAS NOT POSSIBLE TO DETERMINE IF THE SURGERY WAS PERFORMED ACCORDING TO THE SURGICAL TECHNIQUE. AN EXCESSIVE TORQUE APPLIED TO THE SCREWDRIVER MAY HAVE CONTRIBUTE TO SCREW DISASSEMBLY WITHOUT CERTAINTY ABOUT THE CONTEXT HOW IT COULD HAVE BEEN HAPPENED. THIS IS CONSIDERED AS AN ISOLATED CASE DUE TO THE RARE OCCURRENCE (7 CASES IN 5 YEARS) ACCORDING TO FIGURE 1 WITH NO IMPACT ON RISK ANALYSIS. CLARIANCE WILL CONTINUE TO MONITOR THIS TYPE OF EVENT AS PART OF ITS PMS ACTIVITIES AND TREND MONITORING.

    Description of Event or Problem · 0

    THE TECH HAD TROUBLE LOADING THE SCREW ON TO THE NAV DRIVER (B)(6). DURING INSERTION OF THE 9.5X80MM SCREW INTO S2AI (S-2 ALAR ILIAC), THE TULIP HEAD SEPARATED FROM THE BONE SCREW AT THE POINT OF BEING 80% INSERTED. THE T20 SCREWDRIVER WAS THEN USED TO REMOVE THE BONE SCREW. A NEW SCREW WAS USED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO NOTABLE DELAY TO THE SURGERY AND NO COMPLICATIONS FOR THE PATIENT.

    Description of Event or Problem · 0

    THE TECH HAD TROUBLE LOADING THE SCREW ON TO THE NAV DRIVER (48710003). DURING INSERTION OF THE 9.5X80MM SCREW INTO S2AI (S-2 ALAR ILIAC), THE TULIP HEAD SEPARATED FROM THE BONE SCREW AT THE POINT OF BEING 80% INSERTED. THE T20 SCREWDRIVER WAS THEN USED TO REMOVE THE BONE SCREW. A NEW SCREW WAS USED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO NOTABLE DELAY TO THE SURGERY AND NO COMPLICATIONS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840372 ERISMA-LP 9.5MM X 80MM POLYAXIAL SCREW NKG CLARIANCE SAS 18159580 G373X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown