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.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: 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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product code: 07.702.016s lot number: 3h53601 release to warehouse date: 15.08.2023 expiration date: 01.08.2026 supplier: (b)(4) manufacturing site: werk selzach 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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Device report from japan reports an event as follows: it was reported that on (b)(6) 2024, a percutaneous vertebroplasty (th12) for compression fracture was performed with the vbs in question.During the procedure when using the cement in question, after mixing the polymer and liquid, the handle got stuck and cement popped out when the lid was opened to change with the syringe kit adapter.A large amount of cement leaked out that could not be transferred to a syringe, so a new cement kit was opened.The surgery was completed successfully within 30 minutes surgical delay.There was no adverse patient impact, their status is stable.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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