BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK IMPL A8 D3,5 MM/L8 MM

    MDR report key: 19871238 · Received July 31, 2024

    Report

    Report Number
    3013111692-2024-22466
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    March 26, 2023
    Report Date
    September 10, 2024
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532205941
    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

    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.

    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. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK REG C/ABUT GH 3,0 A 0 CATALOG # 17-3070 TO ANK IMPL A8 D3,5 MM/L8 MM CATALOG # 31010205. CORRECTING UDI # FROM TO (B)(4). THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING CONCOMITANT MEDICAL PRODUCTS FROM IMPLANT*2 PRODUCT NUMBER: 31010405, 31010425 TO CONCOMITANT PRODUCT: ABUTMENT 31021625, LOT UNK. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. 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. INVESTIGATION FINDINGS CODE - 3252. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - IMPACT CODE - 4621. MEDICAL DEVICE PROBLEM CODE - 2408. INVESTIGATION FINDINGS CODE - 213. THIS IS FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.

    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
    884966 ANK IMPL A8 D3,5 MM/L8 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK 07392532205941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ABUTMENT 31021625, LOT UNK| IMPLANT*2PRODUCT NUMBER: 31010405, 31010425