BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2279576 · Received October 6, 2011

    Report

    Report Number
    1030489-2011-01259
    Event Type
    Injury
    Date Received
    October 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. THE LOTS THAT WERE USED ARE PART# G7540020, LOT H09F7564, EXPIRATION DATE 06/14/2017; PART #G75446545, LOT H09A1546, EXPIRATION 01/28/2017; LOT H09D4665, EXPIRATION DATE 04/14/2017; PART G84176CHT, LOT 0025650W, EXPIRATION DATE 04/29/2017. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7540020, 510K # K052187 WAS CLEARED IN THE UNITED STATES, 75446545 510K # K042025 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H09F7564 IS 06/18/2009; THE MANUFACTURE DATE FOR LOT H09A1546 IS 02/10/2009; THE MANUFACTURE DATE FOR LOT H09D4665 IS 04/17/2009; THE MANUFACTURE DATE FOR LOT 0025650W IS 05/15/2009. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD POST-OP INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RODS, SCREWS