BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 2287881 · Received October 12, 2011

    Report

    Report Number
    1030489-2011-01311
    Event Type
    Injury
    Date Received
    October 12, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 12, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWQ
    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, LOT H08J7922, EXPIRATION DATE 10/28/2016; LOT H09F7769, EXPIRATION DATE 05/28/2017; LOT H09J3324, EXPIRATION DATE 09/21/17; LOT H10H2810, EXPIRATION DATE 09/03/2018. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8792815, 510K # K030327 WAS CLEARED IN THE UNITED STATES. , THE MANUFACTURE DATE FOR LOT H08J7922 IS 10/29/2008; THE MANUFACTURE DATE FOR LOT H09F7769 IS 06/12/2009; THE MANUFACTURE DATE FOR LOT H09J3324 IS 09/21/2009; THE MANUFACTURE DATE FOR LOT H10H2810 IS 09/03/2010. , 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 CERVICAL SPINAL PROCEDURE AT C4-6 TO TREAT OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT. IT WAS REPORTED THAT SOMETIME POST-OP, THE PATIENT UNDERWENT A REVISION SURGERY BECAUSE ONE OF THE SCREWS WAS SUSPECTED OF BACKING OUT. DURING THE REVISION SURGERY, THE SURGEON CONFIRMED THAT THE PLATE WAS BACKED OUT BECAUSE THE PLATE HAD BEEN PLACED OBLIQUELY AND IT CAUSED LOOSENING OF SCREWS. THE SURGEON SHIFTED THE PLATE PROPER POSITION. NO PATIENT COMPLICATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention PLATE