Catalog Number 07.702.016S |
Device Problems
Device Difficult to Setup or Prepare (1487); Device Difficult to Maintain (3134)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Lot and expiration date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Synthes sales rep.G510(k) - pending clearance.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 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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that during an anterior & posterior lumbar fusion/fixation procedure on (b)(6) 2019, three (3) loads of vertecem v+ cement kit did not work where cement did not come out.There was 20 minutes surgical delay reported.The procedure was successfully completed.The patient condition was good.This complaint involves three (3) devices.This report is for one (1) vertecem v+ cement kit.This report is 1 of 3 for (b)(4).
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Event Description
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It was reported that during an anterior & posterior lumbar fusion/fixation procedure on (b)(6) 2019, three (3) loads of vertecem v+ cement kit did not work well where it does not give the amount of cement that should come out.A small amount of cement was implanted to the patient using the 3 units of vertecem.There was 20 minutes surgical delay reported.The procedure was successfully completed.The patient condition was good.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Protocol # device is not distributed in the united states, but is similar to device marketed in the usa.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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Search Alerts/Recalls
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