BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 5605439 · Received April 25, 2016

    Report

    Report Number
    2520274-2016-12150
    Event Type
    Injury
    Date Received
    April 25, 2016
    Report Date
    April 4, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: (B)(4). THIS REPORT IS FOR AN UNKNOWN SPINE (TITANIUM CAGE SYSTEM) /UNKNOWN QUANTITY/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: CLARKE, M. J. ET AL, (2015) FUSION FOLLOWING LATERAL MASS RECONSTRUCTION IN THE CERVICAL SPINE. J NEUROSURG SPINE, 22:1477-9. USA ARTICLE. THIS ARTICLE PRESENTED 7 CASES IN WHICH LATERAL MASS RECONSTRUCTION WITH A CAGE OR FIBULAR STRUT GRAFT WAS USED TO PROVIDE LOAD-BEARING SUPPORT, INCLUDING 1 CASE OF BILATERAL CAGE PLACEMENT. A RETROSPECTIVE REVIEW WAS PERFORMED OF THE MEDICAL RECORDS OF ALL 7 PATIENTS WHO UNDERWENT LATERAL MASS CAGE PLACEMENT OR FIBULAR STRUT GRAFTING FROM 2007 TO 2009 AT 2 ACADEMIC INSTITUTIONS. CAGES WERE SECURED WITH SMALL FRAGMENT SCREWS (SYNTHES). FOUR MEN (57%) AND 3 WOMEN (43%) WITH AN AVERAGE AGE OF 49 YEARS (RANGE 16¿77 YEARS) WERE TREATED. A NEOPLASTIC PROCESS WAS DIAGNOSED IN ALL PATIENTS. CASE 5: THIS WAS A (B)(6) MAN WHO PRESENTED WITH CERVICAL MYELOPATHY AND A HISTORY OF SURGERY FOR CERVICAL CHORDOMA (C1-C3), FOLLOWED BY RADIOTHERAPY. THE PATIENT UNDERWENT REMOVAL OF POSTERIOR HARDWARE (MANUFACTURER NOT IDENTIFIED IN ARTICLE) AND RECONSTRUCTION OF BILATERAL LATERAL MASSES USING TITANIUM CAGES (MANUFACTURER NOT IDENTIFIED IN ARTICLE). COMPLICATIONS: CSF LEAK, URINARY TRACT INFECTION. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS REPORT IS FOR: UNKNOWN SPINE (TITANIUM CAGE SYSTEM), UNKNOWN QUANTITY, UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258561 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention