(b)(6).Date of postoperative infection development is unknown.510k: this report is for four (4) unknown synfix evolution screws/unknown lot.Part and lot number are unknown; udi number is unknown.510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.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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