BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED EV 3.6 S - 15 MM

    MDR report key: 18491524 · Received January 11, 2024

    Report

    Report Number
    3013111692-2024-00676
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    September 15, 2023
    Report Date
    March 24, 2024
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532132544
    PMA / PMN Number
    K120414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ERROR OCCURRED AND ADDITIONAL INFORMATION WAS NOT SUBMITTED. ADDING ADDITIONAL INFORMATION THAT WAS NOT SUBMITTED IN INITIAL MDR. ADDING: DESCRIBE EVENT OR PROBLEM - IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. UDI#: (B)(4). SECTION G1 PHONE NUMBER REPORTING CONTACT US PHONE: (B)(4). ADDING ADDITIONAL MANUFACTURER NARRATIVE: THIS MDR SUBMISSION IS A LATE SUBMISSION. A CAPA HAS BEEN ISSUED. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION.

    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 UDI # FROM (B)(4). THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ASTRATECH IMPL EV 3.6S 15MM OS CATALOG # 26315 TO OSSEOSPEED EV 3.6 S - 15 MM CATALOG # 25226. 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.

    Description of Event or Problem · 0

    LATE USA. SF CASE (B)(4). IMPLANT LOSS. "DDS CHANGING ABUTMENT AND IMPLANT SCREWED OUT W/ ABUTMENT." FAILED TO ENTER WITHIN 5 DAYS, SEE EMAIL ATTACHED. 1/10/2024, KBE: AWARE DATE WAS BASED ON SF (B)(4).RECEIVED 9/26/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888245 OSSEOSPEED EV 3.6 S - 15 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 185538 07392532132544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention