BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED TX 4.0S - 9 MM

    MDR report key: 17660127 · Received August 31, 2023

    Report

    Report Number
    3013111692-2023-54094
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    October 28, 2021
    Report Date
    October 13, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532108303
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 0

    CORRECTING THE FOLLOWING INFORMATION: CORRECTING UDI # FROM (B)(4). DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM IMPL PICK-UP 3.5/4.0 SHORT CATALOG # 24947 TO OSSEOSPEED TX 4.0S - 9 MM CATALOG # 24941. CORRECTING PRODUCT CODE FROM NDP TO DZE. THIS IS A FOLLOW UP REPORT TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183309 OSSEOSPEED TX 4.0S - 9 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK 07392532108303
    2067868 OSSEOSPEED TX 4.0S - 9 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK 07392532108303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ABUTMENT, UNK