BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECTION COMPONENT ROTATIONAL VERSION, SMALL

    MDR report key: 10909363 · Received November 26, 2020

    Report

    Report Number
    3006721341-2020-00002
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 12, 2020
    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

    ON 2020-11-12, LINKBIO COMPLAINTS DEPARTMENT WAS NOTIFIED OF A REVISION SURGERY SCHEDULED TO TAKE PLACE ON (B)(6) 2020 TO ADDRESS A LOOSENED CONNECTION COMPONENT (PART# 16-2840/02, SN# (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373042 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 67 YR Required Intervention