BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECTION COMPONENT ROTATIONAL VERSION, SMALL

    MDR report key: 11592904 · Received March 30, 2021

    Report

    Report Number
    3006721341-2021-00002
    Event Type
    Injury
    Date Received
    March 30, 2021
    Report Date
    March 30, 2021
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MEGA C IMPLANT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2019 (PART # 16-2840/02, SN (B)(4). THE PATIENT THEN HAD AN INFECTION AND A PARTIAL REVISION WAS DONE ON (B)(6) 2019 (PART # 16-2840/02, SN (B)(4). ON (B)(6) 2021, THE PATIENT DISLOCATED AND A REVISION WAS PERFORMED ON (B)(6) 2021 TO PUT A NEW HINGE COMPONENT (PART # 16-2840/02, SN (B)(4) AND ANTI-LUXATION DEVICE INTO THE PATIENT. DURING THE SURGERY IT APPEARED THAT THE CONNECTOR AXIS WAS DEPLOYED, HOWEVER NOT ALL THE WAY. IT IS UNKNOWN IF THE SCREW BACKED OUT, OR IF IT WAS NEVER PUT IN ALL THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489200 CONNECTION COMPONENT ROTATIONAL VERSION, SMALL CONNECTION COMPONENT ROTATIONAL VERSION, SMALL KRO WALDEMAR LINK GMBH & CO. KG 16-2840/02

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention