BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 6243487 · Received January 11, 2017

    Report

    Report Number
    2520274-2017-10114
    Event Type
    Injury
    Date Received
    January 11, 2017
    Report Date
    January 2, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    YAN, J; ET AL (2014) SURGICAL OUTCOMES OF CERVIOS CHRONOS CAGE IMPLANTATION FOR DEGENERATIVE CERVICAL INTERVERTEBRAL DISK DISORDER. NEUROSURG Q, 24:3, 161-166. THIS REPORT IS FOR AN UNKNOWN CERVIOS CHRONOS (UNKNOWN QUANTITY/UNKNOWN LOT). 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. (B)(4). 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 LITERATURE ARTICLE: YAN, J; ET AL (2014) SURGICAL OUTCOMES OF CERVIOS CHRONOS CAGE IMPLANTATION FOR DEGENERATIVE CERVICAL INTERVERTEBRAL DISK DISORDER. NEUROSURG Q, 24:3, 161-166. THIS IS A RETROSPECTIVE STUDY TO REVIEW THE OUTCOME OF CERVIOS CHRONOS (CCOS) FOR ANTERIOR CERVICAL DISCECTOMY WITH INTERBODY FUSION (ACD-IBF). BETWEEN 2007 AND 2008, 32 PATIENTS (20 MALE, 12 FEMALE) UNDERWENT ACD-IBF WITH 51 CCOS IMPLANTATIONS. THE MEAN AGE OF PATIENTS WAS 52 YEARS (RANGE, 33 TO 71). SEVENTEEN PATIENTS HAD PREOPERATIVE PRESENTING SYMPTOMS INCLUDING BOTH RADICULOPATHY AND MYELOPATHY, AND 15 PATIENTS HAD RADICULOPATHY ONLY. SEVENTEEN PATIENTS RECEIVED ANTERIOR CERVICAL DISCECTOMY WITH FUSION (ACDF) WITH CCOS IMPLANTATION AT A SINGLE LEVEL OF THE SPINE, 12 PATIENTS RECEIVED IMPLANTATION AT 2 LEVELS, AND 3 PATIENTS RECEIVED IMPLANTATION AT 3 LEVELS. THE MOST COMMON LEVEL FOR IMPLANTATION WAS C56. ALL PATIENTS HAD EITHER INTRACTABLE PREOPERATIVE CERVICAL RADICULOPATHY OR MYELOPATHY FOR 3 MONTHS DURATION AND UNDERWENT FOLLOW-UP FOR >2 YEARS. POSTOPERATIVE OUTCOMES WERE CLASSIFIED AS FAVORABLE OR UNFAVORABLE. RIGID BONE FUSION WAS DEFINED AS AN INTERSPINOUS DISTANCE < 2MM ON DYNAMIC LATERAL CERVICAL RADIOGRAPHS AND ABSENCE OF RADIOLUCENT GAPS BETWEEN VERTEBRAL ENDPLATES AND CCOS. ANTERIOR DISK HEIGHT AND INTERBODY HEIGHT WERE USED FOR SUBSIDENCE EVALUATION. THE POSTOPERATIVE OUTCOMES WERE FAVORABLE IN 86.7% AND UNFAVORABLE IN 13.3% OF THE PATIENTS. TWO YEARS AFTER SURGERY, 90.01% HAD RIGID BONE FUSION. THE ANTERIOR DISK HEIGHT WAS INCREASED AT POSTOPERATIVE DAY 1 AND MONTH 3 BUT GRADUALLY DECREASED TO THE PREOPERATIVE HEIGHT AT SIXTH MONTH. THE INTERBODY HEIGHT DID NOT CHANGE SIGNIFICANTLY THROUGHOUT THE FOLLOW-UP. THE SEGMENTAL ANGLE HAD SIGNIFICANT LORDOSIS AT POSTOPERATIVE DAY 1 AND MONTH 3, BUT KYPHOTIC CHANGES GRADUALLY RESTORED THE PREOPERATIVE ANGLE. THE CLINICAL OUTCOME WAS SIGNIFICANTLY RELATED TO THE RIGID BONE FUSION RATE. FURTHERMORE, SMOKING WAS A CONTRIBUTING FACTOR TO POOR CLINICAL OUTCOME, AND DIABETES MELLITUS WAS A CONTRIBUTING FACTOR TO POOR INTERBODY FUSION. THE CCOS CAGE CAN BE SAFELY AND EFFECTIVELY USED AS A DISK SUBSTITUTE AFTER ACD-IBF. IN DIABETES MELLITUS PATIENTS, ADJUVANT-FIXATION INSTRUMENTS MIGHT IMPROVE POSTOPERATIVE BONE FUSION. A COPY THE LITERATURE ARTICLE WILL BE SUBMITTED WITH THE MEDWATCH. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN CERVIOS CHRONOS AND REFERS TO THE SERIOUS INJURY OF UNKNOWN PATIENTS WHO EXPERIENCED LORDOSIS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23508 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE ODP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention