BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC RP 4.3X11.5MM

    MDR report key: 22444799 · Received July 8, 2025

    Report

    Report Number
    9611993-2025-071937
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    April 14, 2025
    Manufacturer
    NOBEL BIOCARE AB GÖTEBORG
    Product Code
    DZE
    UDI-DI
    07332747160529
    PMA / PMN Number
    K062566
    Removal / Correction Number
    MW5168312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MW5168312.

    Additional Manufacturer Narrative · 0

    MW5168312.

    Description of Event or Problem · 0

    FAILURE TO OSSEOINTEGRATE. (B)(6) 2025 20:32:40 CET ((B)(4)). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT MW5168312.

    Description of Event or Problem · 0

    FAILURE TO OSSEOINTEGRATE 16.04.2025 20:32:40 CET (5001035) THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT MW5168312.

    Description of Event or Problem · 0

    FAILURE TO OSSEOINTEGRATE. 16.04.2025 20:32:40 CET (5001035). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT MW5168312.

    Description of Event or Problem · 0

    FAILURE TO OSSEOINTEGRATE 16.04.2025 20:32:40 CET (5001035). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT MW5168312.

    Description of Event or Problem · 0

    FAILURE TO OSSEOINTEGRATE 16.04.2025 20:32:40 CET (5001035). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT MW5168312.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701876 NOBELREPLACE CC RP 4.3X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB GÖTEBORG 13116495 07332747160529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention