This report is for an unknown moss-miami transpedicular screw/ unknown lot.Part and lot numbers are unknown; udi 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.(b)(4).
|
This report is being filed after the review of the following journal article: mohanty s.P., kanhangad m., bhat s.N., chawla s., (2018) morphometry of the lower thoracic and lumbar pedicles and its relevance in pedicle fixation, musculoskeletal surgery volume 102, pages 299¿305, (india).This study aims to assess the morphology of the lower thoracic and lumbar pedicles based on computerized tomographic (ct) scans in indian patients.Between august 2009 and august 2014, 135 consecutive adult patients treated for thoracolumbar and lumbar spinal injuries were included in the study.Of the 135 patients included in the study, 117 were treated by internal fixation of the spine using the moss-miami transpedicular screw system.In the lower thoracic spine, screws of 5 mm diameter and 30 mm length were used, while screws of 6 mm diameter and 35 mm length were inserted in the lumbar spine.The patients were followed up for a minimum period of 2 years.The following complications were reported as follows: forty-one screws breached the pedicle wall.Nine screws penetrated the lateral pedicle cortex.32 screws penetrated the medial pedicle cortex.This is report 10 of 10 for (b)(4).This report is for an unknown moss-miami transpedicular screw.This report is linked to (b)(4).
|