Device is not distributed in the united states, but is similar to device marketed in the usa.Part 07.702.016s, lot 0d53340: release to warehouse date: september 01, 2020.Manufacturing site: (b)(4).Supplier: osartis gmbh.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) reports an event as follows: it was reported that this was a percutaneous vertebroplasty treating compression fracture due to osteoporosis on (b)(6) 2021.There was a cleft in the upper centrum, so a stent was deployed downward.While the cement was additionally applied, it leaked from the lower left centrum.The 3.5ml of the cement was used; the surgeon commented that the last cement addition might have been excessive.No further information is available.This report is for a vertecem v+ cement.This is report 1 of 1 for (b)(4).
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