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) dual diameter rod 3.5 x 5.5, 600.This is report 1 of 11 for (b)(4).
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A review of the receiving inspection (ri) for dual diameter rod 3.5 x 5.5, 600 was conducted identifying that lot number 8683n was released in a single batch.Batch 1: lot qty of (b)(4) units were released on 09 jun 2010 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.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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