BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING CAP, 3.5T

    MDR report key: 7052516 · Received November 22, 2017

    Report

    Report Number
    3009222247-2017-00020
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 27, 2017
    Report Date
    October 26, 2017
    Manufacturer
    MIAMI DEVICE SOLUTIONS LLC
    Product Code
    HRS
    PMA / PMN Number
    141493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE REPORT NUMBERS FOR MEDICAL DEVICES INVOLVED IN THE SAME EVENT DESCRIBED IN THIS SUBMISSION: - 3009222247-2017-00019, - 3009222247-2017-00021, - 3009222247-2017-00022, - 3009222247-2017-00023, - 3009222247-2017-00024, - 3009222247-2017-00025, - 3009222247-2017-00026. ADDITIONAL INFORMATION PER SECTION: WEIGHT IS UNKNOWN DESPITE ATTEMPTS TO OBTAIN THIS INFORMATION FROM REPORTER VIA PHONE. UDI: NOT AVAILABLE. PRIMARY DI NUMBER: (B)(4). INVESTIGATION: THE ACTUAL DEVICE ASSOCIATED WITH THIS MDR WAS NOT RETURNED, THEREFORE THE DEVICE COULD NOT BE INSPECTED AND THE LOT NUMBER IS NOT AVAILABLE FOR A REVIEW OF THE DHR. AN OVERALL REVIEW OF THE DHR, NCR FILES, AND VALIDATION ACTIVITIES WAS CONDUCTED FOR THE PRODUCT SUBJECT OF THIS COMPLAINT. THERE WERE NO FINDINGS THAT COULD HAVE CONTRIBUTED TO THIS MDR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT REVISION SURGERY WAS CONDUCTED FOR A MIAMI DEVICE SOLUTIONS (MDS) PROXIMAL HUMERUS PLATING SYSTEM DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832821 LOCKING CAP, 3.5T LOCKING CAP HRS MIAMI DEVICE SOLUTIONS LLC MDS110301L

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention