Additional procodes: kwp, kwq, mnh, mni, osh.A review of the receiving inspection (ri) for viper2 straight rod, ti (480mm) was conducted identifying that lot number tbypv was released in a single batch.Batch 1: released on april 15, 2019 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/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.(b)(4).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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Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a procedure in the lumbar spine to treat tuberculous spondylitis.On an unknown postoperative date, it was found that two rods had broken off.Patient underwent revision surgery on (b)(6) 2020.Complications with this revision procedure were reported under (b)(4).This report is for a viper2 straight rod-480mm.This is report 1 of 2 for (b)(4).
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