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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: 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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Device report from japan reports an event as follows: it was reported that on (b)(6) 2024, plif (th12, l1, l2) for degenerative disease was performed.During the procedure, screws were inserted on th12 and l2 and the cementation was performed.When the cement in question was injected in l2, the cement looked different from usual, and the surgeon needed to stop halfway through because the cement was coming out around the back.On a later date, it was confirmed that cement had leaked into the spinal canal.The procedure was completed successfully.There were no neurological symptoms and the patient was not affected, their outcome was stable.No additional medical intervention was required.No further information is available.This report is for a vertecem v+ cement kit.This is report 1 of 1 for (b)(4).
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