BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZFX09-ZB-TSV-HLRS

    MDR report key: 25147323 · Received May 12, 2026

    Report

    Report Number
    3008932779-2026-00017
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    January 5, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ZFX GMBH
    Product Code
    NHA
    PMA / PMN Number
    K231915
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER: (B)(4). D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. D9: DEVICE AVAILABILITY UNKNOWN / NOT PROVIDED. D10. CONCOMITANT MEDICAL PRODUCTS. IMPLANT TSVWB11, LOT: 1267935. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROSTHETIC PHASE THE SCREW OF THE ABUTMENT FRACTURED AND COULDN'T BE REMOVED. DESPITE MULTIPLE ATTEMPTS USING STANDARD AND ADVANCED RETRIEVAL TECHNIQUES, REMOVAL OF THE FRACTURED SCREW WAS UNSUCCESSFUL. THE OSSEOINTEGRATION OF THE IMPLANT WAS EXCELLENT AND SHOWED NO SIGNS OF FAILURE. HOWEVER, DUE TO THE IMPOSSIBILITY OF REMOVING THE FRACTURED SCREW AND PROCEEDING WITH THE PROSTHETIC RESTORATION, THE IMPLANT AT TOOTH SITE 36 WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208035 ZFX09-ZB-TSV-HLRS DENTAL SCREW NHA ZFX GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention DENTAL IMPLANT SEE H10 NARRATIVE.