It was reported that on (b)(6) 2018, the patient underwent a debridement of surgical site with removal of retained hardware and bone and open reduction internal fixation (orif) of cranium due to infection.One (1) titanium low profile neuro strut plate, three (3) titanium low profile neuro burr hole cover, and sixteen (16) titanium low profile neuro screw self-drilling was removed due to local infection at the site.Patient initially injured self in a motor vehicular accident (mva) and was ejected from the car.Patient had multiple surgeries to multiple areas including her head and multiple debridements from the initial surgery on (b)(6) 2018.There was no surgical delay.Procedure outcome was successful.Patient is still in coma.This complaint involves twenty (20) devices.Please see the linked complaint (b)(4) which captures the additional 10 devices.This complaint is for one (1) ti low profile neuro strut plate 6 holes.This report is 4 of 10 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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H3, h6: investigation summary: 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.
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