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Catalog Number 07.702.016S |
Device Problems
Migration or Expulsion of Device (1395); Chemical Problem (2893)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 11/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that this was a posterior thoracic and lumbar spinal fusion at l2 treating th12 fracture on (b)(6) 2020.In order to prepare the vertecem v+ cement kit, they mixed monomer liquid and polymer powder as per instruction.Next, the surgeon started injecting the cement into an open cannula.The sales rep asked the surgeon to check viscosity once the cement came out of the syringe.With the help of imaging, the surgeon applied the cement to th10 left, th10 right, l2 left, and l2 right.While he was applying the cement into a screw at l2 right, it was confirmed that the cement had been leaking into the blood vessel near the centrum.It passed 7 minutes and 40 seconds from the cement mixing when the event occurred.The surgeon confirmed by imaging that the cement lump (approximately 4cm long and the diameter equal to a small vessel) had been moving to the patient's heart.They completed the rest of the procedure which was delayed for two hours.They removed the cement lump from the vessel.This report is for one (1) vertecem v+ cement kit, sterile.This is report 2 of 2 for (b)(4).
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Manufacturer Narrative
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Product complaint #(b)(4).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.H10 additional narrative: d4: udi provided for reporting.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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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Search Alerts/Recalls
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