BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANKYLOS CX ABUTMENT

    MDR report key: 16270532 · Received January 31, 2023

    Report

    Report Number
    3013111692-2023-31599
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    February 11, 2022
    Report Date
    March 15, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THIS MDR SUBMISSION IS A LATE SUBMISSION. A CAPA HAS BEEN ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING HEALTH EFFECT - IMPACT CODE 4627. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. ADDITIONAL 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. ADDITIONAL FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING A COMPONENT CODE 887. 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 - 2408 INVESTIGATION FINDINGS CODE - 3221 THE CORRECT CODES FOR THIS COMPLAINT ARE: MEDICAL DEVICE PROBLEM CODE - 1260 INVESTIGATION FINDINGS CODE - 3252 DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL B9.5/D4.5/L9.5 CATALOG # 17-0553 TO UNKNOWN ANKYLOS CX ABUTMENT CATALOG # UNKNOWN ANKYLOS CX ABUTMENT.

    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
    2104567 UNKNOWN ANKYLOS CX ABUTMENT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention