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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Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient underwent a surgical procedure on an unknown date, more than a year ago.
The patient experienced persistent pain, and x-ray images taken showed screw failure.
Concomitant device reported: unknown plate, (part # unknown, lot # unknown, quantity unknown).
This is report 7 of 10 for (b)(4).
This complaint has been updated with the 10 of 13 devices.
Please see the linked complaint (b)(4) for the additional two devices.
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