Objective To report tympanoplasty cases completed with Sheehy Partial Ossicular Replacement Prostheses(PORP).Methods Seventy eight(83 ears) of 89 cases who received Sheehy PORP for ossicular chain reconstructionwere r...Objective To report tympanoplasty cases completed with Sheehy Partial Ossicular Replacement Prostheses(PORP).Methods Seventy eight(83 ears) of 89 cases who received Sheehy PORP for ossicular chain reconstructionwere reviewed.These cases were followed for more than 6 months(mean:21.3 months).The preand post -operative average air conduction thresholds and Air -Bone Gap(ABG) at 0.5,1 and 2 kHz were compared.Results All 83 ears showed uneventful healing at 1 month postoperatively.PORPs in 2 ears without cartilage reinforcement were found dislocated at 3 months.Preoperative hearing thresholds were from 35.75 to 68.5 dB HL(mean:59.13 ± 15.23 dB HL).Postoperative mean hearing threshold improved to 32.23± 13.21 dB HL(P < 0.01).Mean air-bone gap(ABG) improved from 36.95 ± 12.19 dB preoperatively to 21.71 ± 12.05 dB after surgery(P < 0.01).In 68 ears(81.9%),postoperative ABGs were either ≤ 20 dB or improved by 15 dB or more compared to before surgery(defined as satisfactory).Conclusion PORP as a ossicular reconstruction material appears to provide satisfactory results.Attention should be paid to avoid of postoperative dislocation.Long-term outcomes remain to be assessed.展开更多
Purpose:Partial ossicular replacement(PORP)and total ossicular replacement prostheses(TORP)are used to restore ossicular chain function.Despite favorable auditory outcomes,these interventions have associated risks and...Purpose:Partial ossicular replacement(PORP)and total ossicular replacement prostheses(TORP)are used to restore ossicular chain function.Despite favorable auditory outcomes,these interventions have associated risks and complications.This study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications,interventions,and root cause analysis(RCA)findings.Materials and methods:The MAUDE database was searched for Medical Device Reports(MDRs)relating to PORPs and TORPs from 2010 to 2020.MDR event descriptions were reviewed,and adverse events were identified as a device issue,patient issue,and/or packaging issue that occurred intraoperatively or postoperatively.Results:Our search identified 70 MDRs which included 110 reported adverse events.Events consisted of 63 device issues,often due to device breaks and displacements,39 patient issues,including common complaints of hearing loss and erosion,and 8 packaging issues.When comparing PORPs and TORPs,TORPs had more reported device issues whereas PORPs had more packaging issues.Intraoperative device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional surgery.For devices returned to the manufacturer,RCA determined that most breaks were caused by modification and/or mishandling or that the product met specifications with an undetermined cause for the break.Conclusion:Device issues were the most common adverse events and frequently required subsequent intervention.Displacement occurred more often with TORPs and was associated with changes in hearing or erosion.The findings of this study are purely descriptive and may not have direct clinical relevance.展开更多
文摘Objective To report tympanoplasty cases completed with Sheehy Partial Ossicular Replacement Prostheses(PORP).Methods Seventy eight(83 ears) of 89 cases who received Sheehy PORP for ossicular chain reconstructionwere reviewed.These cases were followed for more than 6 months(mean:21.3 months).The preand post -operative average air conduction thresholds and Air -Bone Gap(ABG) at 0.5,1 and 2 kHz were compared.Results All 83 ears showed uneventful healing at 1 month postoperatively.PORPs in 2 ears without cartilage reinforcement were found dislocated at 3 months.Preoperative hearing thresholds were from 35.75 to 68.5 dB HL(mean:59.13 ± 15.23 dB HL).Postoperative mean hearing threshold improved to 32.23± 13.21 dB HL(P < 0.01).Mean air-bone gap(ABG) improved from 36.95 ± 12.19 dB preoperatively to 21.71 ± 12.05 dB after surgery(P < 0.01).In 68 ears(81.9%),postoperative ABGs were either ≤ 20 dB or improved by 15 dB or more compared to before surgery(defined as satisfactory).Conclusion PORP as a ossicular reconstruction material appears to provide satisfactory results.Attention should be paid to avoid of postoperative dislocation.Long-term outcomes remain to be assessed.
文摘Purpose:Partial ossicular replacement(PORP)and total ossicular replacement prostheses(TORP)are used to restore ossicular chain function.Despite favorable auditory outcomes,these interventions have associated risks and complications.This study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications,interventions,and root cause analysis(RCA)findings.Materials and methods:The MAUDE database was searched for Medical Device Reports(MDRs)relating to PORPs and TORPs from 2010 to 2020.MDR event descriptions were reviewed,and adverse events were identified as a device issue,patient issue,and/or packaging issue that occurred intraoperatively or postoperatively.Results:Our search identified 70 MDRs which included 110 reported adverse events.Events consisted of 63 device issues,often due to device breaks and displacements,39 patient issues,including common complaints of hearing loss and erosion,and 8 packaging issues.When comparing PORPs and TORPs,TORPs had more reported device issues whereas PORPs had more packaging issues.Intraoperative device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional surgery.For devices returned to the manufacturer,RCA determined that most breaks were caused by modification and/or mishandling or that the product met specifications with an undetermined cause for the break.Conclusion:Device issues were the most common adverse events and frequently required subsequent intervention.Displacement occurred more often with TORPs and was associated with changes in hearing or erosion.The findings of this study are purely descriptive and may not have direct clinical relevance.
