BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM X 6MM SCREW

    MDR report key: 21106529 · Received January 8, 2025

    Report

    Report Number
    2027754-2025-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 8, 2025
    Manufacturer
    OSTEOMED, LLC
    Product Code
    DZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE THREE REPORTED 1.6MM X 6MM SCREW WERE RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE 1.6MM X 6MM SCREW (PART NUMBER 208-1606, BATCH NUMBER 616864) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE RETURNED SCREWS ALL EXHIBIT A BREAKAGE IN THE THREADED REGION. THESE BREAKAGES OCCURRED AT THE 2ND TURN OF THREAD AS COUNTED FROM THE HEAD; THIS WAS THE SAME FOR ALL THREE SCREWS. IN EACH CASE, THE BREAKAGE APPEARED TO INVOLVE A SINGULAR FRACTURE SURFACE THAT WAS SLIGHTLY TO MODERATELY OBLIQUE TO THE DEVICE AXIS. THE SURFACE WAS SLIGHTLY TEXTURED. THE OBLIQUE SURFACE EXHIBITED SLIGHT WARPING/CUPPING AS THE FRACTURE SURFACE BENDS UPWARDS TO A REGION WHERE IT INTERSECTS THE THREAD FORM. THERE WERE NO IMMEDIATELY VISIBLE / CLEARLY-VISIBLE PROGRESSION/BEACH/SEASHELL MARKS ON THIS SURFACE (I.E. NO SIGNS OF FATIGUE). THERE APPEARED TO BE NO ADDITIONAL TWISTING OR OFF-AXIS BENDING OF THE PORTION OF SHAFT THAT REMAINED ATTACHED TO THE HEAD. THE IN-FIELD EVENT DETAILS NOTE THAT "SURGEON WAS PLACING SCREWS IN L MANDIBLE TO FIXATE THE CUSTOM PLATE"; IT WAS UNCLEAR IF THE NOTED "CUSTOM PLATE" OR ANY CUSTOMIZATIONS MADE TO SAID PLATE IN ANY WAY IMPAIRED THE INSERTION PROCESS OR OTHERWISE WOULD HAVE INCREASED RESISTANCE TO INSERTION. THE IN-FIELD EVENT DETAILS NOTE THAT "PILOT HOLES WERE DRILLED TO ACCOMMODATE (SIC) 6MM STANDARD DRIVE SCREWS. THREE SCREWS BROKE IN SUCCESSION WHILE BEING INSERTED." FURTHERMORE, THE EVENT DENOTES "6MM AUTO-DRIVE SCREWS WERE SUCCESSFULLY PLACED." INDICATING THAT SCREWS OF 6MM LENGTH WERE EVENTUALLY SUCCESSFULLY INSERTED. IF PILOT HOLES WERE PROPERLY DRILLED TO ACCOMMODATE THE NOTED LENGTHS OF 6MM SCREWS, IT IS POSSIBLE THE BREAKAGE MAY HAVE BEEN DUE TO OTHER FACTORS OF THE INSERTION PROCESS (E.G. INSERTION METHOD AS CHOSEN BY THE USER, SURGICAL TECHNIQUE ALIGNMENT OR LACK THEREOF, BONE QUALITY/DENSITY, OTHER ANATOMICAL FACTORS, PARTICULAR CUSTOMIZATIONS MADE TO THE AS-NOTED CUSTOM PLATE, ET CETERA). HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    (REPORT 3 OF 3) IT WAS REPORTED DURING SURGERY THAT THE SURGEON WAS ATTEMPTING TO PLACE SCREWS IN L MANDIBLE TO FIXATE THE CUSTOM PLATE. PILOT HOLES WERE DRILLED TO ACCOMMODATE 6MM STANDARD DRIVE SCREWS. THREE SCREWS BROKE IN SUCCESSION WHILE BEING INSERTED. THE BROKEN PORTION OF SCREWS WERE NOT RETRIEVED. THE SURGERY WAS COMPLETED WITH NO DELAY AFTER SUCCESSFULLY PLACING 6MM AUTO-DRIVE SCREWS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THERE ARE 3 RELATED REPORT NUMBERS FOR THIS EVENT, 2027754-2025-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396526 1.6MM X 6MM SCREW SCREW, FIXATION, INTRAOSSEOUS DZL OSTEOMED, LLC 208-1606 616864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male