Additional product code hwc.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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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Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during an unknown surgery, two of the most distal holes in the medial plate do not allow the screws to approach the locking hole with a variable angle.Therefore, the client decides to leave the implanted plate and fasten with the other remaining holes.There was no reported delay.The patient outcome was unknown.This complaint involves four (4) devices.This is report 3 of 4 for (b)(4).
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