BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMALLY INVASIVE GROWER (MIG)

    MDR report key: 17673579 · Received September 1, 2023

    Report

    Report Number
    3013450937-2023-00187
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 6, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    REVISION SURGERY REQUESTED TO REPLACE COLLAPSED MIG DISTAL FEMORAL REPLACEMENT (STANMORE PIN (B)(4) WITH JTS DISTAL FEMORAL REPLACEMENT. REVISION SURGERY WILL INCLUDE THE EXCHANGE OF PASSIVE TIBIA TO METAL CASED ROTATING HINGE, REBUSHING OF FEMORAL POLY, SUPPLY OF C-COLLARS IN 5MM, 10MM AND 15MM SIZE TO HOLD OUR COLLAPSED MIG DISTAL FEMORAL REPLACEMENT. THE CASE NUMBER FOR THE REVISION SURGERY IS (B)(4) TO BE MANUFACTURED BY ONKOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869824 MINIMALLY INVASIVE GROWER (MIG) MIG DISTAL FEMORAL REPLACEMENT KRO ONKOS SURGICAL PIN 20873 PIN 20873

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Hospitalization