BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 2281957 · Received October 7, 2011

    Report

    Report Number
    1030489-2011-01283
    Event Type
    Injury
    Date Received
    October 7, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 9, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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# G6956420, LOT H10F2858, EXPIRATION DATE 07/09/2018; PART # G6956422, LOT H10F2864, EXPIRATION DATE 07/15/2018; LOT H10F2866, EXPIRATION DATE 07/09/2018; PART G6956430, LOT H10F2880, EXPIRATION DATE 07/23/2018; LOT H10F2911, EXPIRATION DATE 07/15/2018, PART # G6956432, LOT H10D9408, EXPIRATION DATE 07/23/2018, LOT H10G2151, EXPIRATION DATE 07/27/2018. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6958720, 6958722, 6958730, 6958732, 510K # K081297 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H10F2858 IS 07/09/2010; THE MANUFACTURE DATE FOR LOT H10F2864 IS 7/15/2010; THE MANUFACTURE DATE FOR LOT H10F2866 IS 07/09/2010, THE MANUFACTURE DATE FOR LOT H10F2880 IS 07/23/2010, THE MANUFACTURE DATE FOR LOT H10F2911 IS 07/15/2010, THE MANUFACTURE DATE FOR LOT H10D9408 IS 07/23/2010, THE MANUFACTURE DATE FOR LOT H10G2151 IS 07/27/2010. 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 SPINAL SURGERY AT C6-T3 WITH BONE SCREWS AT C6, C7, T2 AND T3. A CT SCAN TAKEN POST OPERATIVELY SHOWED MALPOSITION OF THE BONE SCREWS AT LEFT C6 AND C7. THE PATIENT COMPLAINED OF PROBLEMS WITH THE NERVOUS SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Other SCREWS, RODS