BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

    MDR report key: 4567829 · Received March 4, 2015

    Report

    Report Number
    2520274-2015-11353
    Event Type
    Injury
    Date Received
    March 4, 2015
    Report Date
    February 16, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE: (B)(6) (2014): THE APPLICATION OF A ZERO-PROFILE IMPLANT IN ANTERIOR CERVICAL DISCECTOMY AND FUSION. JOURNAL OF CLINICAL NEUROSCIENCE. VOL 21, 462-466. THIS REPORT IS FOR UNKNOWN ZERO-P IMPLANT/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(6). ADJACENT LEVEL DISC DEGENERATION. 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 SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: WANG (2014): THE APPLICATION OF A ZERO-PROFILE IMPLANT IN ANTERIOR CERVICAL DISCECTOMY AND FUSION. JOURNAL OF CLINICAL NEUROSCIENCE. VOL 21, 462-466. THE CLINICAL EFFICACY OF THE ZERO-P IMPLANT IN THE TREATMENT OF SINGLE LEVEL CERVICAL SPONDYLOTIC MYELOPATHY WAS ANALYZED IN THIS ARTICLE. THE CLINICAL DATA OF 47 PATIENTS WITH SINGLE LEVEL CERVICAL SPONDYLOTIC MYELOPATHY WERE RETROSPECTIVELY ANALYZED. TWENTY-TWO PATIENTS (11 MALE/11 FEMALE, AVG AGE: 50.86) WERE TREATED WITH A ZERO-P IMPLANT (GROUP A) AND 25 (10 MALE/15 FEMALE, AVG AGE: 53.68) WITH A TITANIUM PLATE WITH CAGE (GROUPB) BETWEEN JANUARY 2009 AND SEPTEMBER 2010. OPERATIVE TIME, INTRAOPERATIVE BLOOD LOSS, PREOPERATIVE AND POSTOPERATIVE JAPANESE ORTHOPAEDIC ASSOCIATION (JOA) SCORES AND JOA RECOVERY RATE, DYSPHAGIA INCIDENCE AND ADJACENT SEGMENT DEGENERATION RATE WERE MEASURED. THERE WERE NO INFECTIONS OR HEMORRHAGE IN EITHER GROUP, AND NO HEMATOMAS, FRACTURES OR CHRONIC PAIN IN THE BONE HARVESTING AREA OF THE ILIAC CREST WERE OBSERVED. THERE WERE NO INSTANCES OF BOLT LOOSENING OR RUPTURE OF SCREWS OR THE TITANIUM PLATE. ONLY ONE (4.5%) PATIENT COMPLAINED ABOUT MILD DYSPHAGIA 2 WEEKS AFTER SURGERY IN GROUP A; THE DYSPHASIA DISAPPEARED AFTER 2 MONTHS. THERE WERE EIGHT (32%) PATIENTS WHO COMPLAINED OF DYSPHAGIA IN GROUP B. SIX PATIENTS COMPLAINED ABOUT MILD DYSPHAGIA 2 WEEKS AFTER SURGERY AND TWO PATIENTS COMPLAINED OF MODERATE DYSPHAGIA 3 MONTHS AFTER SURGERY. AFTER CONSERVATIVE TREATMENT, SIX PATIENTS HAD RECOVERED AFTER 2 MONTHS AND ONE PATIENT HAD RECOVERED AFTER 6 MONTHS, BUT ONE PATIENT HAD NO APPARENT RELIEF AT THE LATEST VISIT. THE DIFFERENCES OF THE DYSPHAGIA RATES BETWEEN THE TWO GROUPS WERE STATISTICALLY SIGNIFICANT (P = 0.044). AT THE LAST FOLLOW-UP, AMONG THE 44 ADJACENT LEVELS OF GROUP A, SEVEN LEVELS HAD DISC SIGNAL DEGENERATION OR INCREASED DEGENERATION WITH AN ADJACENT LEVEL DEGENERATION RATE OF 15.9%. GROUP B HAD 12 LEVELS WITH DISC SIGNAL DEGENERATION OUT OF 50 ADJACENT LEVELS, A RATE OF 24.0%, AND THE DIFFERENCE BETWEEN POSTOPERATIVE ADJACENT LEVEL DEGENERATION RATES WAS NOT STATISTICALLY SIGNIFICANT (P = 0.330). THIS REPORT REFERS TO COMPLICATIONS WITH GROUP A. MILD DYSPHAGIA IN ONE PATIENT, ADJACENT LEVEL DEGENERATION IN 7 PATIENTS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ZERO-P IMPLANT, UNKNOWN PART#/LOT# AND UNKNOWN QUANTITY. A COPY OF THE LITERATURE ABSTRACT IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149940 INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention