BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIVE S PLUS IMPL D5.5/L11

    MDR report key: 17265940 · Received July 6, 2023

    Report

    Report Number
    3013111692-2023-47983
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 15, 2023
    Report Date
    August 31, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532208782
    PMA / PMN Number
    K073075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING COMPONENT CODE 887. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING ADDITIONAL TYPE OF INVESTIGATION CODE 10. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING INVESTIGATION CONCLUSIONS CODE 61. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: MEDICAL DEVICE PROBLEM CODE - 1863. INVESTIGATION FINDINGS CODE - 3221 . THE CORRECT CODES FOR THIS COMPLAINT ARE: MEDICAL DEVICE PROBLEM CODE - 2547. INVESTIGATION FINDINGS CODE - 3253 + 114.

    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.

    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
    1888139 XIVE S PLUS IMPL D5.5/L11 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 32262415 492185 07392532208782

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 32266040, 32266190