It was reported, that on (b)(6) 2023, veterinary surgeon reported that hardware became infected in a dog patient.Patient had multiple craniofacial fractures.Hardware was originally implanted on (b)(6)19.She will be removing the hardware later this month ((b)(6) 2023).He have included all of the implants used in the original surgery.They are unsure which ones caused the infection.They will be removing all of the plates & screws.No new hardware will be implanted.This report is for one (1) 1.5 ti mf cortex screw stping flutes 6.This is report 2 of 5 for (b)(4).
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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.Additional procode: hwc,mqn.Device available for evaluation is not expected to be returned for manufacturer review/investigation.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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