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: d1, d2, d3, d4, g4-510k: this report is for an unknown biomaterial - cement: spine/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.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 japan reports an event as follows: it was reported that on september 27, 2023, a percutaneous vertebroplasty (l1) for a compression fracture was being performed.The balloon at the right side was inflated by 3 cc and when the pressure was about to reach 26 atm, it was inflated again.At that time, the balloon got damaged, and the contrast medium leaked into the vertebral body.A stent was placed without problems.The inside of the vertebral body was washed with physiological saline after removing the balloon.Cement was injected as usual, and the procedure was completed without problems.The surgery was completed successfully with no surgical delay.The patient was reported to have some type of infection.This report involves unknown biomaterial - cement: spine.This is report 2 of 2 for (b)(4).
|