BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT TAPERED ONE-PIECE SCR-V 3.5MM 2MM

    MDR report key: 24843133 · Received April 10, 2026

    Report

    Report Number
    0001038806-2026-01931
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024018419
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). D9: DEVICE AVAILABILITY UNKNOWN / NOT PROVIDED D10. CONCOMITANT MEDICAL PRODUCTS TAC2, ABUT TAPERED ONE-PIECE SCR-V 3.5MM 2MM LOT 2019100511 G4: PREMARKET IDENTIFICATION K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ABUTMENTS SCREW WAS FRACTURED. TOOTH LOCATION # 45 AND 47.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255936 ABUT TAPERED ONE-PIECE SCR-V 3.5MM 2MM DENTAL ABUTMENT DZE ZIMVIE US CORP LLC 2019100511 00889024018419

    Patients

    Seq Age Sex Outcome Treatment
    1