(b)(4).Concomitant medical products: nexgen stem extension, catalog # 00598801215, lot # 62382612.Nexgen stem extension, catalog # 00598801215, lot # 62448487.Nexgen headed screw, catalog # 00579104100, lot # 62322511.Nexgen headed screw, catalog # 00579104100, lot # 62293341.Rotating hinge articular surface, catalog # 00588006012, lot # 62384946.Rotating hinge knee femoral component, catalog # 00588001602, lot # 11010060.Foreign: (b)(6).Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0002648920-2019-00049, 0002648920-2019-00050, 0001822565-2019-00294, 0001822565-2019-00295, 0001822565-2019-00297, 0001822565-2019-00298.
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Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.Updated: date of report, event , pma/510k, type of reportable event, if follow-up, what type.
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