BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCIF INSERTION INSTRUMENT

    MDR report key: 8041011 · Received November 6, 2018

    Report

    Report Number
    0009610576-2018-00037
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 5, 2018
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    MQP
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K092336.

    Description of Event or Problem · 1

    TEXT "CRANIAL" HAS BEEN PRINTED AT THE WRONG SIDE OF THE SLEEVE. NO IMPACT FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880933 NEOCIF INSERTION INSTRUMENT SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP BIOMET SPAIN, S.L. N/A 36721-1

    Patients

    Seq Age Sex Outcome Treatment
    1