BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 4549096 · Received February 26, 2015

    Report

    Report Number
    2520274-2015-11219
    Event Type
    Injury
    Date Received
    February 26, 2015
    Date of Event
    April 19, 2013
    Report Date
    February 16, 2015
    Manufacturer
    SYNTHES
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PUBLICATION DATE - CHEN, Y., WANG, X., LU, X., YANG, L., YANG, H., YUAN, W., & CHEN, D. (2013). "COMPARISON OF TITANIUM AND POLYETHERETHERKETONE (PEEK) CAGES IN THE SURGICAL TREATMENT OF MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY: A PROSPECTIVE, RANDOMIZED, CONTROL STUDY WITH OVER 7 YEAR FOLLOW-UP." (22: 1539-1546). THIS REPORT IS FOR AN UNKNOWN SYNCAGE C, UNKNOWN QUANTITY, AND UNKNOWN LOT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 JOURNAL ARTICLE, CHEN, Y., WANG, X., LU, X., YANG, L., YANG, H., YUAN, W., & CHEN, D. (2013). "COMPARISON OF TITANIUM AND POLYETHERETHERKETONE (PEEK) CAGES IN THE SURGICAL TREATMENT OF MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY: A PROSPECTIVE, RANDOMIZED, CONTROL STUDY WITH OVER 7 YEAR FOLLOW-UP." (22: 1539-1546). A STUDY WAS DONE AT A UNIVERSITY HOSPITAL USING SYNTHES TITANIUM SYNCAGE C AND A NON-SYNTHES CAGE FOR USE DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION. A TOTAL OF 80 PATIENTS WERE ENROLLED IN THE STUDY USING THE TITANIUM CAGE AND THE NON-SYNTHES CAGE. TWENTY-NINE PATIENTS USING THE TITANIUM CAGE AND 31 PATIENTS USING THE NON-SYNTHES CAGE COMPLETED THE STUDY. OF THE 29 PATIENTS IMPLANTED WITH TITANIUM CAGE 17 WERE MALE AND 12 WERE FEMALE. THE AVERAGE OF THE 29 PATIENTS WAS 45.7 YEARS. THREE PATIENTS WITHDREW FROM THE STUDY DUE TO NEUROLOGICAL DISEASE. THIS REPORT IS 2 OF 2 FOR (B)(4).. THIS REPORT FOR AN UNKNOWN SYNCAGE C. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135109 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention