Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2011, the patient underwent a cervical-thoracic posterior fusion (c4-t2 excluding c7) for ossification of posterior longitudinal ligament (opll).On (b)(6) 2021 the patient was diagnosed with adjacent segment disease (asd) which required decompression fusion between t2 and t3.All implants fused in 2011 had no defect so the fusion will be extended.The revision of c7, t3 (or up to t4) was planned for (b)(6) 2021.This report is for one (1) si polyaxial screw 5.5 x 5 x 25mm.This is report 10 of 11 for (b)(4).
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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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