BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX62OD

    MDR report key: 1000405 · Received February 19, 2008

    Report

    Report Number
    1818910-2008-00214
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 21, 2008
    Manufacturer
    DEPUY INTL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS SUBLUXATION, FOUND LINER MALALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX62OD 87KWA KWA DEPUY INTL, LTD NA YGF52

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention