BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL SCREW, Ø3.5MM X L28MM

    MDR report key: 6257418 · Received January 17, 2017

    Report

    Report Number
    3009222247-2017-00002
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    December 20, 2016
    Report Date
    December 19, 2016
    Manufacturer
    MIAMI DEVICE SOLUTIONS LLC
    Product Code
    HWC
    PMA / PMN Number
    K141493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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: - 3009222247-2017-00001, - 3009222247-2017-00003. ADDITIONAL INFORMATION PER SECTION: NO INFORMATION OTHER THAN THE MEDICAL RECORD NUMBER IS AVAILABLE. IF EITHER THE SUBMITTER OR THE INITIAL REPORTER IS CONTACTED FOR FOLLOW-UP, THE CASE CAN BE EASILY LOCATED SINCE ONLY ONE MDS PLATING SYSTEM WAS IMPLANTED ON (B)(6) 2016 AND ONLY ONE MDS PLATING SYSTEM WAS REMOVED ON (B)(6) 2016. ADDITIONAL INFORMATION: WEIGHT INFORMATION WAS NOT AVAILABLE. INFORMATION PERTAINING TO MODEL#/LOT #: UDI: NOT AVAILABLE. PRIMARY DI NUMBER: (B)(4). THE 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. 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 AN ADDITIONAL SURGERY WAS REQUIRED FOR A MIAMI DEVICE SOLUTIONS (MDS) PROXIMAL HUMERUS PLATING SYSTEM IMPLANTED ON (B)(6) 2016. WHEN THE PATIENT WAS FIRST SEEN BY A HEALTH PROFESSIONAL, A CLOSED REDUCTION WAS ATTEMPTED BUT IT WAS UNSUCCESSFUL. APPROXIMATELY A WEEK LATER ON (B)(6) 2016, AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE TOOK PLACE USING THE MDS PROXIMAL HUMERUS PLATING SYSTEM. NO COMPLICATIONS WERE REPORTED. ACCORDING TO THE OPERATING SURGEON, FOLLOW-UP VISITS REVEALED SIGNS OF INFECTION AND MALALIGNMENT, THEREFORE REVISION SURGERY WAS NECESSARY. MDS WAS INFORMED ON 12/19/2016 THAT REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2016. DURING REVISION SURGERY, INFECTION WAS CONFIRMED AND IT WAS OBSERVED THAT THE BONE FRAGMENTS HAD FALLEN BACK INTO MALALIGNMENT CAUSING THE FRAGMENTS TO PULL AWAY FROM THE FOUR CORTICAL SCREWS ON THE SHAFT. THE OPERATING SURGEON REMOVED THE FOUR SCREWS PARTIALLY SEPARATED FROM THE SHAFT, REPLACED THEM WITH FOUR NEW SCREWS AND APPLIED LOCKING CAPS. LOCKING CAPS HAD NOT BEEN USED FOR THE SHAFT SCREWS IN THE ORIGINAL IMPLANTATION PROCEDURE. ALL OTHER IMPLANTS WERE FOUND TO BE IN GOOD CONDITION AND WERE LEFT IN PLACE. ANTIBIOTIC POWDER WAS APPLIED AT THE SURGICAL WOUND AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED DURING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39918 CORTICAL SCREW, Ø3.5MM X L28MM CORTICAL SCREW, 3.5MM HWC MIAMI DEVICE SOLUTIONS LLC MDS1102X28 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention