BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCIF INSERTION INSTRUMENT

    MDR report key: 6728974 · Received July 20, 2017

    Report

    Report Number
    0009610576-2017-00028
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 20, 2017
    Report Date
    July 20, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    MQP
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MARKINGS ON THE INSERTION INSTRUMENT ARE NOT READABLE AND IN THE WRONG LOCATION. IT WAS REPORTED THAT DURING THE PROCEDURES IN WHICH THE INSTRUMENT WAS USED, THE CAGES MAY HAVE BEEN IMPLANTED 180° INVERTED DUE TO THE MARKINGS. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508173 NEOCIF INSERTION INSTRUMENT SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP BIOMET SPAIN, S.L. N/A 54501170

    Patients

    Seq Age Sex Outcome Treatment
    1