BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1990216 · Received February 15, 2011

    Report

    Report Number
    1030489-2011-00126
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    NA
    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 #H10A1755 AND H10C5756. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 876-713, 510K # K970806 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H10A1755 IS 02/09/2010, THE EXPIRATION DATE IS 02/09/2018; THE MANUFACTURE DATE FOR LOT H10C5756 IS 03/26/2010, EXPIRATION DATE IS 03/26/2018. 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. PER THE REPORTED EVENT, WE DO NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. 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 PROCEDURE AT C3-C4 TO IMPLANT ANTERIOR FIXATION PLATE AND SCREWS. THE 4.0×13MM SCREW WAS IMPLANTED FIRST. HOWEVER, THE SCREW REACHED CORTICAL BONE THEREFORE IT WAS DECIDED TO BE REMOVED TO CHANGE TO A SMALLER SIZED SCREW. THE 4.0×13MM WAS REPLACED WITH A 4.0×12MM SCREW. THE 4.0X 12MM SCREW SEEMS TO BE NOT VERY STABLE DUE TO THE MULTIPLE INSERTIONS. NO PATIENT COMPLICATIONS WERE REPORTED BEFORE OR AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR