BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED EV 4.8 S - 9 MM

    MDR report key: 18362750 · Received December 20, 2023

    Report

    Report Number
    3013111692-2023-64567
    Event Type
    Injury
    Date Received
    December 20, 2023
    Report Date
    January 24, 2024
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532132742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDING UDI # (B)(4). ADDING IMPLANTED DATE: (B)(6) 2015. ADDING EXPLANTED DATE: (B)(6) 2023. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING ADDITIONAL INVESTIGATION CONCLUSIONS CODE 50. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING HEALTH EFFECT - CLINICAL CODE 2013. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. CORRECTING LOT # FROM UNK TO 171582. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM UNKNOWN ATIS IMPLANT CATALOG # UNKNOWN ATIS IMPLANT TO OSSEOSPEED EV 4.8 S - 9 MM CATALOG # 25243. FDA CODING THAT WAS INITIALLY REPORTED IN THE INITIAL REPORT FOR MEDICAL DEVICE PROBLEM CODE IS BEING CORRECTED FROM CODE 1863 TO 2408. THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

    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.

    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
    1957639 OSSEOSPEED EV 4.8 S - 9 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 171582 07392532132742

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention