BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

    MDR report key: 5821178 · Received July 25, 2016

    Report

    Report Number
    2520274-2016-13622
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    November 14, 2012
    Report Date
    July 18, 2016
    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN ZERO-P 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: QI, M., ET AL (2013) THE USE OF A ZERO-PROFILE DEVICE COMPARED WITH AN ANTERIOR PLATE AND CAGE IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CERVICAL SPONDYLOSIS. THE BONE & JOINT JOURNAL, 95-B: 543-547. A RETROSPECTIVE COHORT STUDY COMPARING THE CLINICAL OUTCOME AND COMPLICATIONS, INCLUDING DYSPHAGIA, FOLLOWING ANTERIOR CERVICAL FUSION FOR THE TREATMENT OF CERVICAL SPONDYLOSIS USING EITHER A ZERO-PROFILE IMPLANT OR AN ANTERIOR CERVICAL PLATE AND CAGE. THE STUDY WAS CONDUCTED FROM MAY 2010 TO MAY 2011. 83 PATIENTS (47 MALE/36 FEMALE PATIENTS, AGES 32 TO 68, WITH A MEAN AGE OF 43.6 YEARS), UNDERWENT FUSION SURGERY WITH THE ZERO-P IMPLANT WITH FOLLOW-UP AT 18.6 MONTHS. 107 PATIENTS (58 MALE/49 FEMALE PATIENTS, AGES 34 TO 71, WITH A MEAN AGE OF 44.9 YEARS) UNDERWENT FUSION SURGERY USING A PLATE AND CAGE WITH FOLLOW-UP AT 19.3 MONTHS. INCLUSION CRITERIA INCLUDED PATIENTS WITH DEGENERATIVE DISEASE BETWEEN C3 AND C7 WITH RADICULOPATHY AND/OR MYELOPATHY WHO HAD NOT RESPONDED TO CONSERVATIVE TREATMENT FOR AT LEAST SIX WEEKS. EXCLUSION CRITERIA INCLUDED DEVELOPMENTAL STENOSIS, OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT AND A PREVIOUS HISTORY OF CERVICAL SPINAL SURGERY. ALL PATIENTS UNDERWENT A RIGHT-SIDED SMITH-ROBINSON DECOMPRESSION, FOLLOWED BY THE INSERTION OF EITHER A ZERO-P IMPLANT OR AN ANTERIOR PLATE AND CAGE FILLED WITH AUTOGRAFT BONE TO RECONSTRUCT THE ANTERIOR COLUMN. ROUTINE ANTEROPOSTERIOR AND LATERAL RADIOGRAPHS, CERVICAL CT AND MRI SCANS WERE OBTAINED TO EVALUATE THE AFFECTED SITE AND TO CONFIRM THE DEGREE OF SPINAL CORD AND NERVE ROOT COMPRESSION. FLEXION-EXTENSION RADIOGRAPHS WERE PERFORMED POST-OPERATIVELY AND AT THREE, SIX, 12 AND 18 MONTHS. ALL PATIENTS IN BOTH GROUPS HAD SIGNIFICANT SYMPTOMATIC AND NEUROLOGICAL IMPROVEMENT. ALL PATIENTS ACHIEVED FUSION AND NO GRAFT MIGRATION OR NONUNION WAS OBSERVED. THERE WAS A HIGHER INCIDENCE OF DYSPHAGIA IN THE PLATE AND CAGE GROUP ON THE DAY AFTER SURGERY AND AT TWO MONTHS POST-OPERATIVELY. NO PATIENT IN THE ZERO-P GROUP AND FIVE IN THE PLATE AND CAGE GROUP HAD DYSPHAGIA AT SIX MONTHS POST-OPERATIVELY. ADDITIONAL COMPLICATIONS INCLUDED A LEAK OF CEREBROSPINAL FLUID IN TWO PATIENTS IN THE ZERO-P GROUP AND THREE PATIENTS IN THE PLATE AND CAGE GROUP. ALL FIVE PATIENTS RECOVERED AFTER TWO WEEKS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ZERO-P SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472313 INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention