BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN XIVE IMPLANT

    MDR report key: 21707358 · Received March 27, 2025

    Report

    Report Number
    3013111692-2025-09407
    Event Type
    Injury
    Date Received
    March 27, 2025
    Report Date
    April 6, 2026
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FRACTURED ABUTMENT HAD LED TO THE IMPLANT BEING NO LONGER RESTORABLE AND WILL BE REMOVED. DENTSPLY SIRONA IMPLANTS IS NOT THE MANUFACTURER OF THE FRACTURED ABUTMENT THAT CAUSED THE EVENT UPDATED PRODUCT AND CATALOG NAME. PRODUCT CODE WAS ALSO UPDATED. NEW VERBIAGE ADDED TO H10. "A FRACTURED ABUTMENT HAD LED TO THE IMPLANT BEING NO LONGER RESTORABLE AND WILL BE REMOVED. DENTSPLY SIRONA IMPLANTS IS NOT THE MANUFACTURER OF THE FRACTURED ABUTMENT THAT CAUSED THE EVENT."

    Additional Manufacturer Narrative · 0

    1924//4627//4075//-//4112//180//22. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - IMPACT CODE - 4621. MEDICAL DEVICE PROBLEM CODE - 1260. INVESTIGATION FINDINGS CODE - 3252. THE PHYSICAL INVESTIGATION OF THE RETURNED ITEMS REVEALED THAT NO FRACTURE HAD OCCURRED. THE CORRECT CODES FOR THIS COMPLAINT ARE: MEDICAL DEVICE PROBLEM CODE - 4075, INVESTIGATION FINDINGS CODE - 180, THIS IS A FOLLOW UP REPORT TO CORRECT THESE/THIS CODE(S).

    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 DUE TO SCREW FRACTURE - CUSTOMER ORDERED RESCUE SERVICE, RESCUE SERVICE BY DR. WAS NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493144 UNKNOWN XIVE IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1