BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORNERSTONE-SR CAGE SYSTEM

    MDR report key: 2460664 · Received February 17, 2012

    Report

    Report Number
    1030489-2012-00172
    Event Type
    Death
    Date Received
    February 17, 2012
    Date of Event
    February 11, 2012
    Report Date
    February 13, 2012
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    ODP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEATH. NO FURTHER INFORMATION IS PROVIDED.(B)(4). 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE UNITED STATES, HOWEVER, A LIKE DEVICE, PRODUCT CODE MQP, 510K # K041197, HAS BEEN APPROVED FOR SALE IN THE UNITED STATES. MANUFACTURING DATE 09/2011. EXPIRATION DATE 09/2019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND DEAD AFTER IMPLANT SURGERY. PATIENT'S FAMILY MEMBER CALLED TO NOTIFY COMPANY. NO FURTHER DETAILS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR ANTERIOR FUSION WITH ANTERIOR CERVICAL PLATE AND PEEK INTERBODY DEVICE TO TREAT CERVICAL DISC HERNIATION AND SPINAL STENOSIS. THE PATIENT DIED THE DAY FOLLOWING SURGERY DUE TO LARYNGEAL EDEMA. THERE WERE NO COMPLICATIONS DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORNERSTONE-SR CAGE SYSTEM ODP MSD DEGGENDORF MFG 6272416 UK68

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CATALOG # 6272416, LOT# UT48