BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK C/X IMPL B9.5/D4.5/L9.5

    MDR report key: 16434985 · Received February 24, 2023

    Report

    Report Number
    3013111692-2023-34963
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    January 26, 2022
    Report Date
    March 23, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K083805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - IMPACT CODE - 4627 MEDICAL DEVICE PROBLEM CODE - 1260 COMPONENT CODE - 887 INVESTIGATION FINDINGS CODE - 3252 THE PHYSICAL INVESTIGATION OF THE RETURNED ITEMS REVEALED THAT NO FRACTURE HAD OCCURRED. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - IMPACT CODE - 4621 MEDICAL DEVICE PROBLEM CODE - 2408 DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK REG C/ABUT GH 4,5 A 0 CATALOG # 17-3080 TO ANK C/X IMPL B9.5/D4.5/L9.5 CATALOG # 31010428.

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. SECTION 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
    1993963 ANK C/X IMPL B9.5/D4.5/L9.5 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention CATALOG NO.: 31010428LOT NO.: UNKQTY: 1PC.