BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK REG /X ABUT GH 1,5 A 0

    MDR report key: 20047557 · Received August 23, 2024

    Report

    Report Number
    3013111692-2024-25674
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    June 20, 2024
    Report Date
    September 12, 2024
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    NHA
    UDI-DI
    07392532217401
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CB
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: ADDING CONCOMITANT MEDICAL PRODUCTS IMPLANT (B)(6). THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. 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 ADDITIONAL HEALTH EFFECT - IMPACT CODE: 462. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL B9.5/D4.5/L9.5 CATALOG # 17-0553 TO ANK REG /X ABUT GH 1,5 A 0 CATALOG # 31024120. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING UDI# FROM (B)(4). THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING PRODUCT CODE FROM DZE TO NHA. 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: MEDICAL DEVICE PROBLEM CODE - 1863. INVESTIGATION FINDINGS CODE - 3221. THE CORRECT CODES FOR THIS COMPLAINT ARE: MEDICAL DEVICE PROBLEM CODE - 1260. INVESTIGATION FINDINGS CODE - 3252. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. REMOVING IMPLANTED, DATE (B)(6) 2024. REMOVING EXPLANTED, DATE (B)(6) 2024. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    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
    1387439 ANK REG /X ABUT GH 1,5 A 0 ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IMPLANTS MANUFACTURING GMBH UNK 07392532217401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention IMPLANT 31010428