Device was used for treatment, not diagnosis.(b)(6).This report is for one unknown drill bit.Part and lot numbers were not provided by reporter.Device is an instrument and is not implanted/explanted.(b)(4) unanticipated x-rays related to complained events.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.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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