BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)

    MDR report key: 19178565 · Received April 25, 2024

    Report

    Report Number
    3005180920-2024-00155
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKG
    UDI-DI
    07630040723688
    PMA / PMN Number
    K182837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 4 APRIL 2024: LOT 1921821: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2019. EXPIRATION DATE: 2024-MAY-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 4 APRIL 2024: MUST MINI 03.75.849 MUST MINI OC PRE-BENT TRANSITION ROD 60° Ø3.5/4X 200MM (STE) (K182837) LOT 1921820: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2019. EXPIRATION DATE: 2024-MAY-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: BASED ON THE EVENT DESCRIPTION, IT WAS ASSUMED THAT IT WAS RATHER CHALLENGING TO POSITION THE PRE-BENT ROD INTO THE SCREW HEAD BECAUSE OF THE TRANSITION AREA WAS TOO CLOSE TO THE SCREW HEAD. THE TRANSITION AREA IS LOCATED 5MM UNDER THE RADIUS, AND IT IS LONG 5MM DECREASING FROM Ø4 TO Ø3.5MM. THIS AREA IS INTENTIONALLY IDENTIFIED IN SILVER COLOR TO PREVENT BOTH THE RADIUS AND THE TRANSITION ZONE FROM BEING MATCHED TO THE CONNECTOR OF THE OC PLATE. THIS LATTER IS IDENTIFIED IN GOLD COLOR TO ENSURE PROPER MATCHING OF THE AREA Ø4MM WHILE PREVENTING FAILURE DURING THE FINAL TIGHTENING PROCEDURE. IN THE CASE OF VERY PARTICULAR ANATOMY, A STRAIGHT TRANSITION ROD IS ALSO AVAILABLE FOR CONTOURING ACCORDING TO A SPECIFIC PATIENT'S ANATOMY. VISUAL INSPECTION WAS PERFORMED ON THE RETRIEVED DEVICE WITH NO EVIDENCE OF ABNORMAL ASPECTS ALONG THE PRE-CURVED SHAFT.

    Description of Event or Problem · 0

    SPINAL FIXATION WAS PERFORMED AT OCCIPITAL BONE-C2/C3. THE SURGEON HAD DIFFICULTY SEATING MUST MINI OC PRE-BENT TRANSITION ROD INTO THE SCREW HEAD AT THE RIGHT SIDE OF C2 (TWO RODS WITH DIFFERENT ANGLES WERE TRIED). THE PART HE WAS TRYING TO SEAT WAS SILVER AND NOT GOLD, THEREFORE HE THOUGHT THE DIAMETER WAS 3MM, WHILE IT WAS MORE THAN 3MM AND SO COULD NOT BE PLACED INTO THE SCREW TULIP. A STRAIGHT ROD WAS USED TO COMPLETE THE SURGERY. ABOUT A 1-HOUR DELAY OVER A TOTAL SURGERY TIME OF 4 HOURS AND 30 MINUTES. THE SCREW WHICH WAS INSERTED AT THE C2 WAS REF:03.75.006,LOT:1923635 AND REF:03.75.006,LOT:2227122. NO PROBLEM ON THE LEFT SIDE OF C2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605859 MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE) SPINE TRANSITION ROD NKG MEDACTA INTERNATIONAL SA 1921821 07630040723688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other