BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 11.5MMX21.5CM 125 L

    MDR report key: 24977243 · Received April 24, 2026

    Report

    Report Number
    0009613350-2026-00217
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - EVENT OCCURRED IN JAPAN. D10: CONCOMITANT MEDICAL PRODUCTS: DESC: Z NAIL CMF 10.5 X 100 LAG SCR; ITEM: 47-2499-100-10; LOT: 3202857. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 1 YEAR POST-IMPLANTATION DUE TO LAG SCREW MIGRATION AND THE PATIENT COMPLAINED OF PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610078 Z NAIL CMF 11.5MMX21.5CM 125 L ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER GMBH 3141710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.