BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR? ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 4334756 · Received December 16, 2014

    Report

    Report Number
    1030489-2014-04742
    Event Type
    Injury
    Date Received
    December 16, 2014
    Date of Event
    November 18, 2014
    Report Date
    November 18, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). MIGRATION OF DEVICE OR DEVICE COMPONENT. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # 8792113 WITH 510K # K994239 OF A 'LIKE DEVICE' WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS 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 A PATIENT WITH CERVICAL SPONDYLOTIC MYELOPATHY UNDERWENT A CERVICAL FUSION AT C5-C7 (C6 SUBTOTAL EXTIRPATION WITH 1 ABOVE AND 1 BELOW CERVICAL PLATE CONSTRUCT). INTRAOPERATIVELY, SCREWS WERE INSERTED AND REMOVED SEVERAL TIMES BECAUSE THE "INSERTION ANGLE WAS DIFFICULT". DUE TO THIS REINSERTION, 4.0 DIAMETER-SCREW WAS CHOSEN FOR THE LEFT CRANIAL SIDE. POST-OPERATIVELY, THE PATIENT REPORTED DISCOMFORT AND UNDERWENT A REVISION SURGERY APPROXIMATELY 8 MONTHS LATER DUE TO SCREW LOOSENING. NO RE-FIXATION WAS APPLIED AFTER REMOVING IMPLANTS. NO BREAKAGE WAS SEEN WITH THE LOCKING MECHANISM. IT WAS REPORTED THAT 4 SCREWS CAME OFF ANTERIORLY ALONG WITH THE PLATE. AS THE SURGEON CONSIDERED THAT RE-FIXATION WAS NOT NECESSARY, ONLY REMOVAL OF IMPLANTS WAS PERFORMED. NO ADDITIONAL BONE GRAFTING WAS PERFORMED AS WELL. THE SURGEON COMMENTED THAT ALL THE SCREWS WERE INSERTED AT RIGHT ANGLES TO THE PLATE, SO MOVEMENTS IN DAILY ACTIVITIES MIGHT HAVE CAUSED SCREW LOOSENING ALONG WITH THE PLATE. ADDITIONALLY, THE SURGEON STATED THAT "SEVERAL ATTEMPTS OF SCREW INSERTION AS WELL AS THE INITIALLY REPORTED SCREW INSERTION ANGLES MIGHT HAVE CAUSED THE INCIDENT". THE PATIENT¿S POSTOPERATIVE CLINICAL COURSE WAS REPORTED AS "WELL WITHOUT A SENSE OF DISCOMFORT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823986 ZEPHIR? ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention CERVICAL PLATE SYSTEM