BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP RECONSTRUCTION PROSTHESIS

    MDR report key: 9223627 · Received October 23, 2019

    Report

    Report Number
    3004371426-2019-00130
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 2, 2019
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    JDI
    PMA / PMN Number
    K142187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. ALL PRODUCT FEATURES CORRESPOND WITH THE VALID SPECIFICATIONS OF THE WALDEMAR LINK GMBH & CO. KG AT THE TIME, WHEN THE PRODUCT WAS PRODUCED.

    Description of Event or Problem · 0

    ON 2019-10-02, LINKBIO COMPLAINTS DEPARTMENT WAS NOTIFIED OF A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2019 TO ADDRESS AN EXPANSION BOLT THAT "BACKED OUT" AFTER IT WAS ORIGINALLY IMPLANTED ON (B)(6) 2017 (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).

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. ALL PRODUCT FEATURES CORRESPONDED WITH THE VALID SPECIFICATIONS OF THE WALDEMAR LINK GMBH & CO. KG AT THE TIME, WHEN THE ITEM WAS PRODUCED.

    Description of Event or Problem · 1

    ON 2019-10-02, LINKBIO COMPLAINTS DEPARTMENT WAS NOTIFIED OF A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2019 TO ADDRESS AN EXPANSION BOLT THAT "BACKED OUT" AFTER IT WAS ORIGINALLY IMPLANTED ON (B)(6) 2017 (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
    1020897 MP RECONSTRUCTION PROSTHESIS EXPANSION BOLT JDI WALDEMAR LINK GMBH & CO. KG 172-947/38 1703003

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention