(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.Sample not returned for evaluation.
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Reported thru legal: on (b)(6) 2014, patient was required to have the defective, unsafe and/or undersized screws surgically removed by surgeon as the defective, unsafe and/or undersized screws had broken and completely failed.As a direct and proximate result of the dangerous, defective, unsafe, and/or undersized screws placed into patient's body, plaintiffs have suffered and will continue to suffer noneconomic loss including severe injury and disability, including physical and mental pain and suffering, and will continue to experience such injuries into the future.
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