BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ROBOTIC UNIT DRAPE BOX 20

    MDR report key: 11739693 · Received April 28, 2021

    Report

    Report Number
    0009617840-2021-00003
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 28, 2021
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    UDI-DI
    50748426123976
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). 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 · 1

    IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING. OUR INCOMING INSPECTION TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639027 ROSA ROBOTIC UNIT DRAPE BOX 20 ORTHOPEDIC STEREOTAXIC INSTRUMNET OLO ZIMMER CAS N/A D202331 50748426123976

    Patients

    Seq Age Sex Outcome Treatment
    1