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: e1: initial reporter is j&j company representative 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.
|
Device report from synthes reports an event in japan as follows: it was reported during a posterior fusion for ovf on (b)(6) 2024 with synflate and fenestrated screws, the synflate was completed with the usual technique and a verse fenestrated screw was inserted.There were no problems with the screw installation position.After about 10 minutes of waiting after cement mixing, the cement viscosity was checked and the cement was starting to be injected.During injection, cement was found to be leaking into the blood vessels, and injection was stopped.Additional injections were made after confirming that the leaking cement had not migrated through the vessel.However, the injection was stopped again as it leaked into the vessel again.The procedure was then completed after confirming that the cement has not migrated within the vessel.Postoperative x-rays also showed cement leaking into the vessels.Patient is stable.Surgical delay is unknown.No information is known on the mixing or storage of the cement.Remarks: (b)(4) and (b)(4) are involved with the same event.(b)(4) (synthes spine): cement.(b)(4) (depuy spine): screws.This report is for one vertecem v+ cement kit for (b)(4).
|