BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP RECONSTRUCTION PROSTHESIS

    MDR report key: 9170098 · Received October 8, 2019

    Report

    Report Number
    3006721341-2019-00011
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 2, 2019
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 2019-10-02, LINKBIO COMPLAINTS DEPARTMENT WAS NOTIFIED OF A REVISION SURGERY THAT TOOK PLACE ON 2019-10-01 TO ADDRESS AN EXPANSION BOLT THAT "BACKED OUT" AFTER IT WAS ORIGINALLY IMPLANTED ON 2017-10-11 (CATALOG 172-947/38, LOT # 1703003). THE BACKED-OUT EXPANSION BOLT WAS INITIALLY IMPLANTED WITH AN MP RECONSTRUCTION PROSTHESIS SYSTEM NECK SEGMENT (CATALOG 172-984/26, LOT # 160502/3252) AND A 180 MM MP STEM (CATALOG 172-918/18, LOT # 1705224).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959147 MP RECONSTRUCTION PROSTHESIS EXPANSION BOLT,HEX 8 MM LZO WALDEMAR LINK GMBH & CO. KG 172-947/38

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention