BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL SCREW, Ø3.5MM X L22MM

    MDR report key: 6729431 · Received July 20, 2017

    Report

    Report Number
    3009222247-2017-00009
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    June 29, 2017
    Report Date
    June 21, 2017
    Manufacturer
    MIAMI DEVICE SOLUTIONS LLC
    Product Code
    HWC
    PMA / PMN Number
    K141493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP CORRECTION: THE INITIAL MEDWATCH REPORT MISTAKENLY REFERENCES REPORT 3009222247-2017-00018 AS RELATING TO THE SAME EVENT. REPORT 3009222247-2017-00018 IS NOT ASSOCIATED IN ANYWAY WITH THIS MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE REPORT NUMBERS FOR MEDICAL DEVICES INVOLVED IN THE SAME EVENT DESCRIBED IN THIS SUBMISSION: - 3009222247-2017-00007, - 3009222247-2017-00008, - 3009222247-2017-00010, - 3009222247-2017-00011, - 3009222247-2017-00012, - 3009222247-2017-00013, - 3009222247-2017-00014, - 3009222247-2017-00015, - 3009222247-2017-00016, - 3009222247-2017-00017, - 3009222247-2017-00018. - ADDITIONAL PRODUCT CODE: HRS: PLATE, FIXATION, BONE. 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 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 PLATING SYSTEM IMPLANTED ON (B)(6)2017. REVISION WAS DUE TO NONUNION. DURING REMOVAL SURGERY ALL IMPLANTS WERE FOUND TO BE IN GOOD CONDITION. ALL PARTS WERE EXPLANTED AND REPLACED WITH NEW MDS IMPLANTS, WHICH INCLUDED A LONGER PROXIMAL HUMERUS PLATE THAN THE ONE ORIGINALLY IMPLANTED. SURGERY WAS COMPLETED WITHOUT ANY KNOWN COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510276 CORTICAL SCREW, Ø3.5MM X L22MM CORTICAL SCREW HWC MIAMI DEVICE SOLUTIONS LLC MDS1102X22 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention