BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL TOP - BUTTON TOP IMPLANT SCREW

    MDR report key: 1024469 · Received April 3, 2008

    Report

    Report Number
    1718476-2008-00001
    Event Type
    Injury
    Date Received
    April 3, 2008
    Date of Event
    March 10, 2008
    Report Date
    April 2, 2008
    Manufacturer
    RMO, INC.
    Product Code
    DZE
    PMA / PMN Number
    K033767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - ONLY 3MM OF THE DEVICE HEAD IS AVAILABLE FOR EVAL. THE REMAINING 5MM WAS DESTROYED DURING THE EXTRACTION PROCESS BY THE ORAL SURGEON. INITIAL VISUAL INSPECTION CONDUCTED BY RMO, INC, INDICATES THAT THE SCREW FAILURE IS DUE TO TORSIONAL FORCES APPLIED DURING INSERTION. THE DEVICE HAS BEEN RETURNED TO THE ORIGINAL MFR FOR FURTHER EVAL AND TESTING. F/U ADD'L INFO WILL BE REPORTED UPON THE RECEIPT OF THE INVESTIGATION FINDINGS FROM THE ORIGINAL MFR. ORIGINAL MFR: JEIL MEDICAL CORP.

    Description of Event or Problem · 1

    VERBAL CONVERSATION WITH DR (NITIAL RPTR) IN 2008: DR STATED THAT THE MINI-SCREW BROKE DURING INSERTION THE FOLLOWING DAY. SUBSEQUENTLY, THE BROKEN PIECE OF THE IMPLANTED SCREW WAS REMOVED BY AN ORAL SURGEON ONE DAY PRIOR, DUE TO PT DISCOMFORT. THE SCREW TWISTED OFF DURING IMPLANT. X-RAYS SHOW HIGH BONE DENSITY. THE DR ALSO STATED THAT THIS WAS HIS FIRST USE OF THE SCREWS FROM RMO; HOWEVER, THE DR ALSO STATED THAT HE HAD EXPERIENCE USING THE MINI-SCREWS FROM OTHER COMPETITORS, AND THAT HE HAD NOT OVERLY TWISTED THE SCREW DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL TOP - BUTTON TOP IMPLANT SCREW IMPLANT, ENDOSSEOUS, ROOT-FORM DZE RMO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention