BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT

    MDR report key: 19627436 · Received June 26, 2024

    Report

    Report Number
    MW5156737
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Report Date
    June 14, 2024
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IMPLANT PLACED INTO SITE #4 WHICH UPON PLACEMENT WAS DISLODGED INTO THE MAXILLARY SINUS. SINUS PERFORATION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815519 DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE STRAUMANN MANUFACTURING, INC. 34125

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female