A1: (b)(6).B4: (b)(6)2021.G3: 01-aug-2021.G6: follow-up #1.H2: additional information.Medical device problem code: 2682 - patient - device incompatibility.H10: radiographic images showed evidence of osteolysis.Microbiology and histology results were provided and showed no positive results.This report is made by the manufacturer without prejudice and does not imply an admission of liability for the incident or its consequences.Limited information was provided; notably, no pre-operative, and post-operative, interim, or flexion/extension radiographs were provided.Without such information it is not possible to assess the potential role of patient conditions, m6-c placement, and surgical technique.As such, we are reporting this incident to err on the side of caution.Spinal kinetics' post-market surveillance procedures require multiple attempts to gain as much detailed information as possible regarding the reported event.
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