BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AARHUS SCREW

    MDR report key: 8055091 · Received November 9, 2018

    Report

    Report Number
    8010099-2018-00002
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MEDICON E.G.
    Product Code
    DZE
    UDI-DI
    04046826385446
    PMA / PMN Number
    K041527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW WAS SUBJECT TO VISUAL INSPECTION. THE OUTER RIM OF THE SCREW HEAD WAS SEVERELY DEFORMED AND HALF OF THE SCREW DRIVE WAS BROKEN OFF. TESTING WAS PERFORMED ON THREE IDENTICAL SCREWS FROM ANOTHER BATCH TO DETERMINE THE FORCE REQUIRED TO PRODUCE A SIMILAR FRACTURE BY MEANS OF THE REGULAR SCREW TIGHTENING PROCESS. AS THE FORCE INCREASED, THE SCREW HEAD WAS HOLLOWED OUT BY THE DRIVER, STRIPPING THE SCREW COMPLETELY WITHOUT BREAKING IT. THE TYPE OF DAMAGE WAS COMPLETELY DIFFERENT. THE TEST RESULTS INDICATE THAT WHEN THE CORRECT PROCEDURE FOR SCREW INSERTION IS FOLLOWED, APPLICATION OF EXCESSIVE FORCE WILL NOT PRODUCE THE TYPE OF DAMAGE SHOWN BY THE RETURNED SCREW. PRIOR TO INSERTING A SCREW, IT MUST BE ALIGNED CORRECTLY IN THE SCREWDRIVER SLEEVE. IF IT IS INSERTED IN THE SLEEVE IN A SLANTED POSITION, THE LINE OF INSERTION MAY ALSO BE ANGLED, DAMAGING THE OUTER RIM OF THE SCREW HEAD AND MAKING COMPLETE INSERTION IMPOSSIBLE. PRESUMABLY THAT IS WHAT OCCURRED IN THIS CASE TO CAUSE THE DEFORMATION OF THE OUTER RIM OF THE SCREW HEAD. AND WHEN THE HEALTHCARE PROVIDER ATTEMPTED TO REMOVE THE SCREW WITH FORCEPS, A FRAGMENT OF THE SCREW HEAD BROKE OFF AS DESCRIBED.

    Description of Event or Problem · 1

    THE ORTHODONTIC SCREW HEAD BROKE AS THE SCREW WAS BEING REMOVED FROM THE PATIENT'S JAW. THE BROKEN PIECE WAS RETRIEVED IMMEDIATELY AND SCREW REMOVAL WAS COMPLETED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894645 AARHUS SCREW ORTHODONTIC SCREW DZE MEDICON E.G. 094546/300415 04046826385446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention