Product complaint : (b)(4).Pc: surgical intervention, medical device removal.(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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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It was reported that on (b)(6) 2019, the patient underwent revision surgery due to the left side l4, l5, s1, and lateral connector locking cap popped off and were replaced with s1 screw with larger diameter screw and new locking caps.On (b)(6) 2017, the patient had t5-pelvis fusion.Procedure was successfully completed.Patient outcome is unknown.This complaint involves five (5) devices.
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