BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 11.5MMX21.5CM 125 L

    MDR report key: 24625202 · Received March 18, 2026

    Report

    Report Number
    0009613350-2026-00171
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 18, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CONCOMITANT MEDICAL PRODUCTS: DESC: Z NAIL CMF 10.5 X 85 LAG SCR; ITEM: 47-2499-085-10; LOT: 3241725. G2: FOREIGN - EVENT OCCURRED IN JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL FIXATION PROCEDURE. APPROXIMATELY FOUR WEEKS POSTOPERATIVELY, THE SURGEON CONFIRMED FROM X-RAYS THAT THE LAG SCREW HAD BACKED OUT. THE PATIENT IS BEING MONITORED, AND NO REVISION SURGERY IS PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686295 Z NAIL CMF 11.5MMX21.5CM 125 L ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER GMBH 3241772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11 NARRATIVE.