BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED TX 5.0 - 13 MM

    MDR report key: 21228001 · Received January 24, 2025

    Report

    Report Number
    3013111692-2025-01821
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    November 22, 2024
    Report Date
    March 4, 2025
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532108204
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND OUR LONG-TIME EXPERIENCE IN THE INVESTIGATION OF SIMILAR COMPLAINTS. PRODUCT RETURN IS REQUESTED AND PRODUCT WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: ADDING UDI# (B)(4). THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. ADDING CODES: HEALTH EFFECT - CLINICAL CODE: 1930. TYPE OF INVESTIGATION CODE: 10. INVESTIGATION FINDINGS CODE: 3243. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM UNKNOWN ATIS ABUTMENT CATALOG # UNK ATIS ABUTMENT TO OSSEOSPEED TX 5.0 - 13 MM CATALOG # 24963. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING CONCOMITANT MEDICAL PRODUCTS FROM 24963-137625 TO UNKNOWN ATIS ABUTMENT. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING PRODUCT CODE FROM NHA / COMMON DEVICE NAME ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS TO DZE/COMMON DEVICE NAME IMPLANT, ENDOSSEOUS, ROOT-FORM. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED 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
    556354 OSSEOSPEED TX 5.0 - 13 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 137625 07392532108204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 24963-137625| UNKNOWN ATIS ABUTMENT.