(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: may 28, 2015.Expiry date: march 01, 2017.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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It was reported the surgeon had issues with the synflate balloon.A 10g access needle, tamp, drill (due to hard bone), a large 20mm balloon, and vertecem cement were used.Surgeon had a really hard time pushing the large balloon down the working cannula after he drilled.After five (5) minutes of fighting with the balloon, and changing gloves to get a better grip, surgeon finally was able to insert the balloon into the cannula and then into the vertebral body.There was a five minute surgical delay; the procedure was successfully completed.This is report 1 of 1 for com-(b)(4).
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