BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 17653343 · Received August 29, 2023

    Report

    Report Number
    MW5145085
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Report Date
    August 24, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IMPLANT BROKE AT THE APEX OF THE IMPLANT. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). VISIT DIAGNOSES, PRIMARY: TOOTH LOSS K08.109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438947 SCREW ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Female AMOXICILLIN (AMOXIL) 500 MG CAPSULE.| CHLORHEXIDINE (PERIDEEX)0.12 % SOLUTION.| HYDROCODONE-ACETAMINOPHEN| IBUPROFEN 600 MG.