BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2846471 · Received November 27, 2012

    Report

    Report Number
    1030489-2012-02441
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOTS THAT WERE USED ARE PART# 54740004525, LOT H12E2902, EXPIRATION DATE 05/31/2020; LOT H12E2054, EXPIRATION DATE 06/06/2020; LOT H12E0930, EXPIRATION DATE 06/06/2020; LOT H12E0141, EXPIRATION DATE 05/12/2020; LOT H12C3269, EXPIRATION DATE 04/11/2020. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840004525, 510K # K091974 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H12E2902 IS 05/31/2012; THE MANUFACTURE DATE FOR LOT H12E2054 IS 06/06/2012; THE MANUFACTURE DATE FOR LOT H12E0930 IS 06/06/2012; THE MANUFACTURE DATE FOR LOT H12E0141 IS 05/12/2012; THE MANUFACTURE DATE FOR LOT H12C3269 IS 04/11/2012. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AT L3-L5 TO TREAT DEGENERATIVE SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY 4 DAYS POST-OP DUE TO PARALYSIS CAUSED BY A HEMATOMA. NO ADDITIONAL PATIENT INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention VB REPLACEMENT