BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS PLATE, 3 HOLE LEFT

    MDR report key: 6903777 · Received September 29, 2017

    Report

    Report Number
    3009222247-2017-00018
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    August 30, 2017
    Report Date
    August 29, 2017
    Manufacturer
    MIAMI DEVICE SOLUTIONS LLC
    Product Code
    HRS
    PMA / PMN Number
    K141493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PER SECTION: AGE AND WEIGHT ARE UNKNOWN DESPITE ATTEMPTS TO OBTAIN THIS INFORMATION. (B)(4). ORIGINAL IMPLANTATION SURGERY DATE IS UNKNOWN. 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 AND NCR FILES FOR THE PRODUCT SUBJECT OF THIS COMPLAINT WAS CONDUCTED. 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 PLATE DUE TO NONUNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683304 PROXIMAL HUMERUS PLATE, 3 HOLE LEFT PROXIMAL HUMERUS PLATE HRS MIAMI DEVICE SOLUTIONS LLC MDS130103L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention