Our patient complained of acute swelling rit was reported that on (b)(6) 2023, the patient complained of acute swelling in the right cheek.He was admitted with antibiotics and examination under anesthesia ( eua).Pus seemed to be in the cheek but was tracked from the plate.The plate and the surrounding granulation tissue along with the lose screws were removed.They were soaked in peroxide and betadine but required a slightly larger (emergency) screw to replace the 6 mm screws that were originally in place.In the operation room (or) prior to anesthetizing the patient, it was communicated by the patient that the left side was becoming sore and the skin on that side was starting to point.Upon visual observation, the mouth area (which had not yet been opened) appeared to have proof of granulation tissue.It was noted that 24 screws were most likely needed to be replaced with 6-8-10mm lengths as emergency 2.4 screws.This report is for one (1) matmand scr ø2 self-tap l6 fine-pitch th.This is report 12 of 12 for complaint: (b)(4).
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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.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: date of concomitant therapy is 1/24/2023.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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