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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 synthes reports an event in japan as follows: it was reported that this was a percutaneous vertebroplasty (l1) for compression fracture on (b)(6) 2023.The surgery was completed successfully without any surgical delay.After the surgery, when the sale rep was talking to the surgeon on dec.26, 2023, he found that the cement from (b)(6) 29th was leaking.The surgeon said that it flowed through the blood vessels to the lungs, but it did not stay in the lungs, but stopped in the blood vessels.The patient does not have a pulmonary embolism, and the surgeon has already explained what has happened.The pain is gone and the patient has already been discharged from the hospital.The patient is scheduled for further follow-up.No further information is available.This report is for one (1) vertecem v+ cement kit this is report 1 of 1 for complaint (b)(4).
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