This is report 2 of 2 for (b)(4).This report is being filed after the review of the following journal article: klepinowski t., sagan l., (2022) euroqol-5 dimensions health-related quality of life questionnaire in craniovertebral instability treated with posterior fixation with or without occipital plating: a comparative study with matched datasets, j craniovert jun spine volume 13, issue 1, pages 72-79 (poland).This observational study aims to present the first study of both adults and pediatrics, which shall detect the baseline hrqol before craniocervical fusion and at follow-up.Between 2006 and 2021, 60 patients (30 males and 30 females) who underwent posterior craniocervical junction fusion at the tertiary neurosurgical center due to cci were included in the study.The mean age of the group at the time of operation was 37.2 years (sd = 26.5).During c1-c2 fixation via lateral masses of c1 and pedicles of c2, either summit® si oct spinal fixation system instruments (depuy synthes, usa; n = 54) or synapse¿ oct system (depuy synthes, usa; n = 6) was used.Occipital plating was done if gross atlanto-occipital instability was present and for type a basilar invagination of goel¿s classification[15] with separate analysis for each group (with occipital plating versus without).The median follow-up for eq-5d was 26.3 months with an interquartile range (iqr) of 10.8 to 47.3 months.The following complications were reported as follows: abnormal postoperative radiological evaluation : (n=26) dens to mcrae line, (n=7) dens to chamberlain line, (n=7) dens to mcgregor line, dens to wackenheim line (n=19) , (n=16) revised condyle-c1 interval, (n=7) basion-dens interval, (n=13) basion-axial interval, (n=4) sagittal diameter at c1, (n=4)sagittal diameter at fm.(n=3) neurological status, deteriorated postoperatively.(n=19) myelopathy did not improve.14 cortical breach.This report is for an unknown depuy spine summit® si oct spinal fixation system instruments.
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If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma/510k: this report is for an unknown device/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.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.Without a lot number the device history records review could not be completed.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.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.Report was initially submitted on may 20, 2022; advised by fda on may 20, 2022 after hours to resubmit medwatch.Medwatch report is being resubmitted on may 23, 2022.
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