Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: wang, b., lu, g.And kuang, l.(2018), anterior cervical discectomy and fusion with stand-alone anchored cages versus posterior laminectomy and fusion for four-level cervical spondylotic myelopathy: a retrospective study with 2-year follow-up, bmc musculoskeletal disorders, vol.19 (216), pages 1-7 (china).The purpose of this retrospective study is to compare the clinical and radiological outcomes of acdf using stand-alone anchored cages to that of laminectomy with fusion (lf) for treating four-level csm.Between january 2012 and january 2014, a total of 58 patients were included in the study and were divided in 2 groups.Among these, 32 patients (16 male, 16 female; mean age 54.4 ± 11.7 years) underwent posterior laminectomy and fixation using axon® (synthes inc., raynham, ma, usa) (group b).Postoperative follow-up visits were performed at 1 week, 3 months, 6 months, 12 months, 18 months, and 24 months after surgery, and every year thereafter.The following complications were reported as follows: group b: the cervical lordosis improved at postoperative 1 week, 3 months, 6 months, 12 months, but decreased at postoperative 18 months and 24 months; loss of lordosis in the cervical spine and fused segment was 7.5 ± 3.8° and 3.7 ± 3.4°.Patient had superficial infection.Patients complained of pain and paresis of the unilateral deltoid, which was considered to be c5 palsy, within 1 week postoperatively.Patients developed axial neck pain at postoperative 6 months, two of them had recovered by the final follow-up, while one patient suffered persistent pain.This report is for an unknown synthes axon.This is report 1 of 1 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.This report is for an unknown screw/rod construct acc: axon/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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