BEUDAMED
    FDA Adverse Event Death Summary report: N

    CD HORIZON

    MDR report key: 2340313 · Received November 17, 2011

    Report

    Report Number
    1030489-2011-01505
    Event Type
    Death
    Date Received
    November 17, 2011
    Date of Event
    October 18, 2011
    Report Date
    October 18, 2011
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART# G75446540, LOT H11E3111, EXPIRATION DATE: 07/05/2019; LOT H11E5615, EXPIRATION DATE: 07/07/2019; LOT H11E5618, EXPIRATION: DATE 07/01/2019; PART #G75446545, LOT H11C2635, EXPIRATION DATE: 04/04/2019; LOT H11C2636, EXPIRATION DATE: 04/18/2019; LOT H11C3705, EXPIRATION DATE: 04/19/2019; LOT H11C3706, EXPIRATION DATE: 04/04/2019; LOT H11C4589, EXPIRATION DATE: 04/30/2019. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 75446540, 75446545, 510K # K042025 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H11E3111, MFG DATE: 07/05/2011; LOT H11E5615, MANF DATE: 07/07/2011; LOT H11E5618, MANF DATE: 07/01/2011; LOT H11C2635, MANF DATE: 04/04/2011; LOT H11C2636, MANF DATE: 04/18/2011; LOT H11C3705, MANF DATE: 04/19/2011; LOT H11C3706, MANF DATE: 04/04/2011; LOT H11C4589, MANF DATE: 04/30/2011. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGERY AT TH11-L4 TO TREAT INJURIES FOLLOWING AN ACCIDENT. IT WAS REPORTED THAT DURING PLACEMENT OF THE ROD THE PATIENT'S BLOOD PRESSURE DROPPED CRITICALLY AND THE CASE WAS ABORTED. THE PATIENT WAS TRANSFERRED TO THE ICU. THE PATIENT EXPIRED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death SCREWS