BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1030489-2016-01695

    MDR report key: 5702611 · Received June 7, 2016

    Report

    Report Number
    1030489-2016-01695
    Event Type
    Injury
    Date Received
    June 7, 2016
    Date of Event
    November 1, 2013
    Report Date
    May 11, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 7200052/ LOT: UNK (X1) PART: 905-901/ LOT: UNK (X1) PART: 3120316/ LOT: UNK (X4) ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART # 7200052. ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT UNSPECIFIED SPINAL PROCEDURE IN WHICH PLATE WAS IMPLANTED. POST OPERATIVELY,PATIENT REPORTED HAVING CHRONIC PAIN AND INFLAMMATION AT THE SITE,ELEVATED PLATELETS,ELEVATED CORTISOL,AUTOIMMUNE SYMPTOMS. PATIENT HAS NOT BEEN TESTED FOR METAL ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358491 KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other