There are multiple patients all information is provided in the article.This report is for an unknown mono/polyaxial screws/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between july to september 2003.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).
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This report is being filed after the review of the following journal article: mizuno, k.Et al (2005), intraoperative insertion torque of lumbar pedicle screw and postoperative radiographic evaluation: short-term observation, journal of orthopaedic science, vol.10 (2), pages 137-144 (japan).The aim of this study is to analyzed the factors that affect insertion torque use with a custom-made torquemeter driver in vivo.Between july to september 2003, a total of 23 patients (5 male and 18 female) with an average age of 68 years (range 49-86 years) underwent lumbar pedicle screw fixation.Surgery was performed using moss miami system (depuy spine, raynham, ma, usa) in 8 patients (10-disc levels).Follow-up was unknown.The following complications were reported as follows: 17 screws showed "cortex cutting" (screw threads cut into the anterior cortex of the vertebral body).In the moss miami group, one-disc level with radiolucent zones was observed, and one level with motion of more than 5° and with a radiolucent zone was seen; there were two of eight-disc levels that showed ¿3-month instability.¿ this report is for an unknown moss-miami.This report is for one unknown mono/polyaxial screw.This is report 2 of 10 for (b)(4).This complaint is linked to (b)(4).
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