BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL FIXATION DEVICE

    MDR report key: 1970496 · Received January 20, 2011

    Report

    Report Number
    1526439-2011-00005
    Event Type
    Injury
    Date Received
    January 20, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K041119
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS LIMITED AND NO CONNECTION CAN BE MADE BETWEEN THE REPORTED PROBLEM AND ANY SHORTCOMING OF THE DEVICE OR INFO SUPPLIED WITH THE DEVICE. THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE LIST FOREIGN BODY SENSITIVITY AS A POSSIBLE ADVERSE OUTCOME. IN CONVERSATION THE CONTACT WAS INFORMED THAT SHE SHOULD DISCUSS THIS WITH THE IMPLANTING SURGEON OR AN ALLERGIST WHO MAY BE ABLE TO DETERMINE IF HER DAUGHTER IS EXPERIENCING A METAL SENSITIVITY RESPONSE.

    Description of Event or Problem · 1

    MOTHER OF PT IMPLANTED WITH XPDM 6.35 STAINLESS STEEL IMPLANTS REPORTS THAT HER DAUGHTER MAY BE EXPERIENCING A REACTION TO THE METAL IMPLANTS. THE INFO SHE PROVIDED WAS LIMITED. A COMPLAINT WAS OPENED TO DOCUMENT THIS ISSUE. SINCE AN EVENT OF THIS NATURE COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION AN MDR IS FILED TO DOCUMENT THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL FIXATION DEVICE KWP DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention