BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 25109980 · Received May 7, 2026

    Report

    Report Number
    0001038806-2026-02483
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    August 17, 2023
    Report Date
    May 7, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED D1: BRAND NAME: UNKNOWN / PROVIDED D4: ADDITIONAL DEVICE INFORMATION: UNKNOWN / NOT PROVIDED G4: PREMARKET IDENTIFICATION PMA/510(K) #: UNKNOWN / NOT PROVIDED H4: DEVICE MANUFACTURER DATE: UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED AS AN EMERGENCY DUE TO DISCOMFORT WHEN BITING HARD. THE DOCTOR REMOVED THE ORTHODONTIC APPLIANCE, DISASSEMBLED THE BRIDGE OVER THE IMPLANT-SUPPORTED PROSTHESIS, AND FOUND A FRACTURED SCREW AT 14 AND A FAILED IMPLANT AT TOOTH 16. IMPLANT AT TOOTH SITE 16 WAS REMOVED DUE TO NON INTEGRATION AND CURETTAGE WAS PERFORMED. PROCEDURE WAS NOT COMPLETED THIS REPORT REFERS TO FRACTURED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115673 DENTAL SCREW NHA ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female INT3211.