BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 15553485 · Received October 6, 2022

    Report

    Report Number
    0002023141-2022-02495
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Report Date
    October 6, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: DENTAL IMPLANT: TSVTWB10, IMP, TSV, 4.7, 10, MTX, MG, LOT NUMBER: 1233824. PMA/510(K) NUMBER NOT AVAILABLE. NO DEVICE CATALOG OR LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. SINCE THE DEVICE WILL NOT BE RETURNED, IDENTIFYING A DEFINITIVE ROOT CAUSE WILL NOT BE POSSIBLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH IDENTIFIES THE PRODUCT OR INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DOCTOR FOUND A FRACTURED CROWN ON IMPLANT SITE #19. IT BECAME LOOSE AND THE DOCTOR STATED THE MOVEMENT FROM THE CROWN CAUSED THE SCREW LOOSENING AND THREAD DAMAGE. THE SCREW WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2801164 DENTAL SCREW NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DENTAL IMPLANT.