BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

    MDR report key: 6283207 · Received January 27, 2017

    Report

    Report Number
    2520274-2017-10304
    Event Type
    Injury
    Date Received
    January 27, 2017
    Date of Event
    February 29, 2016
    Report Date
    January 25, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN ZERO-P SYSTEM (UNKNOWN QUANTITY/UNKNOWN LOT). (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; 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 SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: CHEN, G; WU, W; LYU, J; XIANG, K (2016) CLINICAL OUTCOME OF A NEW ZERO-PROFILE IMPLANT USED IN PATIENTS WITH CERVICAL SPONDYLOSIS: A RETROSPECTIVE STUDY WITH A MAXIMUM OF 43 MONTHS FOLLOW-UP. INT J CLIN EXP MED 9(2):2237-3344. THIS STUDY AIMS TO ANALYZE COLLECTED CLINICAL AND RADIOLOGICAL DATA IN PATIENTS WHO UNDERWENT SINGLE- OR MULTILEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION USING ZERO-P IMPLANT (SYNTHES GMBH, OBERDORF, SWITZERLAND). FROM JULY 2009 TO FEBRUARY 2013, 56 PATIENTS UNDERWENT CERVICAL SPONDYLOSIS WAS TREATED IN OUR HOSPITAL. AT THE END OF FOLLOWING PERIODS, 51 OF THE PATIENTS WERE ASSIGNED TO UNDERGO-ING ANTERIOR CERVICAL DISCECTOMY AND FUSION USING THE NEW IMPLANT. THERE WERE 28 MALES AND 23 FEMALES IN THIS STUDY, WHICH WERE AVERAGE 54.1±11.16 YEARS OLD. THE COURSE OF DISEASE WERE 1 TO 140 MONTHS (AVERAGE 25 MONTHS) WITH 12 TO 43 MONTHS¿ FOLLOW-UP. THREE PATIENTS AT 1 MONTH AND 1 PATIENT AT 6 MONTHS COMPLAINED ABOUT MILD DYSPHAGIA-RELATED SYMPTOMS. IN THE FOLLOW-UP, WE OBSERVED NO IMPLANT DISPLACEMENT AND VERTE¬BRAL INSTABILITY. THERE WERE 39 OF THE 51 PATIENTS WHO ACHIEVED SOLID FUSION 6 MONTHS AFTER SURGERY, AND 49 OF THE PATIENTS ACHIEVED SOLID FUSION 1 YEAR AFTER SURGERY. AT THE END OF THE 3 CASES OF INCOMPLETE HEALING THE PATIENTS WERE FOLLOW-UP FOR 1 YEAR. A COPY OF THE LITERATURE ARTICLE WILL BE SUBMITTED WITH THE MEDWATCH. THIS REPORT IS FOR 1 OF 1 FOR COM-(B)(4). THIS REPORT IS FOR AN UNKNOWN ZERO-P SYSTEM AND REFERS TO THE SERIOUS INJURY OF 4 UNKNOWN PATIENTS WITH MILD DYSPHAGIA RELATED SYMPTOMS AND 3 UNKNOWN PTS HAD INCOMPLETE HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65921 INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention