BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK

    MDR report key: 23777596 · Received December 11, 2025

    Report

    Report Number
    MW5180317
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) CALLED TO REPORT THAT THEIR NAVLOCK WAS GETTING STUCK ON THEIR TAP. (B)(6) SAID THAT THE NAVLOCK DIDN'T GET STUCK WHEN HE WAS PRESENT, BUT HE WAS GOING TO INVESTIGATE THE ISSUE FURTHER. THE ACCOUNT ATTEMPTED MULTIPLE TAPS, AND A RING INDENT WAS LEFT ON THE TAP FROM IMPROPER ATTACHMENT TO THE NAVLOCK. (B)(6) WILL INFORM (B)(6) WHICH PARTS WOULD NEED TO BE QUOTED, IF ANY. THIS ISSUE DIDN'T CAUSE A DELAY IN THE CASE. THEY SWITCHED OUT THE NAVLOCK TO PROCEED WITH THE SURGERY. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554910 NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown