(b)(4) multiple mdr reports were filed for this event, please see associated reports: mfr#0001822565-2018-00953.(b)(6).Concomitant medical products: tibial insert component size 3 blue plus cat#: 00830005300, lot#: 63090112.Tibial base component cat#: 00830004300, lot#: 63096504.Talar component cat#: 00830001300, lot#: 63112686.One- third tubular plate with collar 9 holes cat#: 00493500903, lot#: 63518815.Trabecular metal total ankle screw cat# unk lot# unk.Reported event was confirmed by review of x-rays provided.X-ray review show loosening and breakage of the 2 syndesmotic screws, with syndesmotic screws backing out by several millimeters and syndesmotic screw heads no longer flush with the plate.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history review cannot be performed without product identification.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
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