BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 7002652 · Received November 6, 2017

    Report

    Report Number
    0001825034-2017-09920
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 6, 2017
    Report Date
    January 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    PK110879
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED, BUT THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A COMPLAINT HISTORY SEARCH WAS PERFORMED AND NO ACTIONS ARE REQUIRED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 912082, JGRKNT 1.0 MM MINI 3-0 NDLS, 038300. (B)(6). CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017- 09919. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THE ANCHORS WERE PULLED OUT FROM THE PATIENT'S BURR HOLES. ONE OF THE PRODUCTS WAS RETAINED IN THE PATIENT'S BODY. THE SURGEON DRILLED ADDITIONAL HOLES AND USED AN ALTERNATIVE PRODUCT TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782631 JGRKNT 1.0MM MINI 3-0 NDLS FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A 154740

    Patients

    Seq Age Sex Outcome Treatment
    1