Product complaint # (b)(4).Gtin: unknown.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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Mr.(b)(6) used concorde inline implants for a patient around this time.Recently he has let me know, that the same patient has come back to clinic for a check up, and one of the concorde inline cages is backing out.He said hes concerned and he doesn¿t know why that is happening, but is going to keep an eye on it.Any advise?.
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