BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM X 4MM PROFILE ZERO AUTODRIVE SCREW

    MDR report key: 14640757 · Received June 9, 2022

    Report

    Report Number
    2027754-2022-00035
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    June 8, 2022
    Report Date
    July 15, 2022
    Manufacturer
    OSTEOMED, LLC
    Product Code
    GWO
    UDI-DI
    00845694034258
    PMA / PMN Number
    K111176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS CURRENTLY PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    FIVE (5) SCREWS WERE RECEIVED FOR EVALUATION. QUALITY CONTROL ASSESSED THE SCREW HEAD DIAMETER ON THE FIVE (5) RETURNED PARTS BASED ON THE COMPLAINT DESCRIPTION OF THE SCREW FALLING THROUGH THE PLATE. ALL FIVE (5) SCREW HEADS WERE WITHIN SPECIFICATION. A 2-YEAR REVIEW OF THE COMPLAINTS DATABASE REVEALED NO OTHER COMPLAINTS FOR THIS ISSUE WITH THIS PART NUMBER. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING THE CRANIOPLASTY PROCEDURE ON (B)(6) 2022, THE PHYSICIAN WAS IMPLANTING SCREWS (PART NUMBER 218-1604) INTO A PROFILE ZERO SQUARE PLATE. WHEN THE SCREW HEAD INTERFACED WITH THE PLATE, THE SCREW "SLIPPED" RIGHT THROUGH THE PLATE HOLE AND INTO THE BONE. IT WAS REPORTED IT APPEARED AS IF THE SCREW HEADS WERE SMALLER THAN THE PLATE HOLES. THIS ISSUE OCCURRED WITH SEVERAL SCREWS AS A PLATE THE SURGEON THOUGHT WAS SECURE "LIFTED" UP LEAVING THE SCREWS IN THE BONE AND UNATTACHED TO THE PLATE. THE 218-1604 SCREWS WERE REMOVED AND REPLACED WITH PART NUMBER 218-1605 SCREWS WHICH SECURED THE PLATE FLUSH TO THE BONE WITH NO ISSUES. IT WAS REPORTED THE FIVE 218-1604 SCREWS INVOLVED IN THIS EVENT ARE BEING RETURNED FOR EVALUATION. THIS REPORT IS RELATED TO REPORT NUMBERS 2207754-2022-00031, 2207754-2022-00032, 2207754-2022-00033, AND 2207754-2022-00034 FOR THE OTHER SCREWS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678825 1.6MM X 4MM PROFILE ZERO AUTODRIVE SCREW PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE GWO OSTEOMED, LLC 218-1604 1170273 00845694034258

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male