BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSP METATARSAL SHORTENING SYSTEM

    MDR report key: 15708497 · Received November 1, 2022

    Report

    Report Number
    3009540749-2022-00007
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Report Date
    November 1, 2022
    Manufacturer
    MEDARTIS INC.
    Product Code
    HWC
    PMA / PMN Number
    K140724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS PROVIDED THAT CHANGES THE OUTCOME OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    PLATE WAS REMOVED FROM PATIENT BECAUSE IT HAD BROKEN. PATIENT HAD A NON-UNION. CASE WAS DONE AT HOLLY HILL SURGERY CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482078 MSP METATARSAL SHORTENING SYSTEM PLATE HWC MEDARTIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention