Patient information is not available for reporting.Udi # (b)(4).Implant and explant dates: device malfunction occurred during the procedure.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation as the material was reportedly discarded.Initial reporter contact number: (b)(4).Pma 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.Device history records review was completed for part # 07.702.016s, lot # 5e53130.Manufacturing location: (b)(4).Manufacturing date: sep 09, 2015 expiry date: may 31, 2018.Review of the device history records 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 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)(4) reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, patient underwent initial surgery for percutaneous with vertebral augmentation.During the surgery, the handle of the mixer became stuck and made it impossible to use the cement.Another cement was used.The cement was injected into the vertebra l1 in which two stents were deployed.The surgery was prolonged about five (5) minutes.No impact to patient reported.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for (b)(4).
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