BEUDAMED
    FDA Adverse Event Death Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 6543327 · Received May 4, 2017

    Report

    Report Number
    1030489-2017-01074
    Event Type
    Death
    Date Received
    May 4, 2017
    Date of Event
    April 2, 2017
    Report Date
    September 4, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING PRODUCTS WERE IMPLANTED INCLUDING: CATALOG# 75445545, 75445540, 75445535, 75444535,75444540, 7540020, 869-022; LOT # UNK; 510K# K042025, K042025, K042025, K042025, K042025,K052187, K040962 ; UDI: (B)(4); QTY. 4, 3, 1, 4, 2, 14, 2. ALTHOUGH IT IS UNKNOWN IF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES ONLY. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADD'L INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SMITH-PETERSEN OSTEOTOMY AT T7-8, T8-9, T9-10. DURING THE SURGERY, THE PATIENT BLED OUT AS A RESULT OF WHICH BLOOD TRANSFUSION WAS REQUIRED. ACCORDING TO THE PHYSICIAN, THE INSTRUMENT AND IMPLANT SIZES MAY NOT HAVE MATCHED. ON (B)(6) 2017, POST-OP, PATIENT DIED DUE TO CARDIAC ARREST.

    Description of Event or Problem · 1

    PER REP, PATIENT WAS STABLE IMMEDIATELY FOLLOWING THE CASE. DURING THE PROCEDURE, THERE WERE NO COMPLICATIONS OBSERVED THAT COULD HAVE LEAD TO THIS OUTCOME. THE PROCEDURE WAS SUCCESSFUL WITH INSTRUMENTATION AND NO ISSUES WITH SURGEON IMPLEMENTATION WAS OBSERVED. THE PART OF TRANSFUSION WAS SUCCESSFUL AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327755 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death| O