BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

    MDR report key: 5837803 · Received August 1, 2016

    Report

    Report Number
    2520274-2016-13795
    Event Type
    Injury
    Date Received
    August 1, 2016
    Report Date
    July 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. DATE OF EVENT: SHIN, J., OH, S., CHO., O. (2014) SURGICAL OUTCOME OF A ZERO-PROFILE DEVICE COMPARING WITH STAND-ALONE CAGE AND ANTERIOR CERVICAL PLATE WITH ILIAC BONE GRAFT IN THE ANTERIOR CERVICAL DISCECTOMY AND FUSION, KOREAN J SPINE, 3: 169-77. THIS REPORT IS FOR AN UNKNOWN SPINE (ZERO-PROFILE DEVICE)/UNKNOWN QUANTITY/UNKNOWN LOT. UDI: UNKNOWN PART NUMBER: UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE 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: SHIN, J., OH, S., CHO., O. (2014) SURGICAL OUTCOME OF A ZERO-PROFILE DEVICE COMPARING WITH STAND-ALONE CAGE AND ANTERIOR CERVICAL PLATE WITH ILIAC BONE GRAFT IN THE ANTERIOR CERVICAL DISCECTOMY AND FUSION, KOREAN J SPINE, 3: 169-177. COUNTRY OF ARTICLE: KOREA. THIS WAS A RETROSPECTIVE STUDY OF 60 PATIENTS WITH CERVICAL DISC DISEASE WHO WERE TREATED WITH A SINGLE LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FROM JANUARY 2008 TO JUNE 2013. PATIENTS WERE DIVIDED INTO 3 TREATMENT GROUPS; ZERO-PROFILE (SYNTHES (B)(4)) DEVICES IN GROUP A (N=20), STAND-ALONE PEEK CAGES (UNKNOWN MANUFACTURER) IN GROUP B (N=20) AND CERVICAL ANTERIOR PLATES (UNKNOWN MANUFACTURER) WITH AUTOLOGOUS ILIAC BONE GRAFTS IN GROUP C (N=20). THE PURPOSE OF THE STUDY WAS TO EVALUATE THE RADIOLOGICAL CHANGES AS WELL AS CLINICAL OUTCOMES IN THE APPLICATION OF ZERO-PROFILE DEVICES COMPARED WITH STAND-ALONE CAGES AND ANTERIOR CERVICAL PLATES WITH ILIAC BONE GRAFTS FOR THE CERVICAL DISEASE. ONLY THE COMPLICATIONS FOR PATIENTS IN GROUP A WILL BE INCLUDED IN THIS COMPLAINT. COMPLICATION: GROUP A (ZERO-PROFILE DEVICE); DYSPHAGIA ¿ (N=1). THIS REPORT IS 2 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SPINE (ZERO-PROFILE DEVICE), UNKNOWN QUANTITY AND UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489448 INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention