BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5115823 · Received October 1, 2015

    Report

    Report Number
    1030489-2015-02541
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 3, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF DEATH IS UNKNOWN. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 7221745 / LOT: 0218580W(X2) PART: 7221750 / LOT: 0269931W(X2) PART: 7221750 / LOT: 0162651W PART: 7221750 / LOT: 0273635W ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    TYPE OF PROCEDURE OR TECHNIQUE USED: STANDARD OPEN SURGICAL TECHNIQUE FOR PEEK ROD IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT DIED DURING THE SURGERY. THE CAUSE OF DEATH AND CIRCUMSTANCES SURROUNDING THE DEATH IS UNKNOWN AT THIS POINT IN TIME. RESULT OF AUTOPSY IS NOT AVAILABLE. THE IMPLANTED SCREWS REMAIN IN SERVICE, INSIDE THE PATIENT. THE SCREWS DID NOT BREAK. NO FURTHER INFORMATION IS AVAILABLE. DATE OF DEATH: (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646529 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Other