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Model Number XOM UNK PROSTHESIS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Therapeutic Response, Decreased (2271)
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Event Type
Injury
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Manufacturer Narrative
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Product evaluation: analysis results are not available; devices not returned for evaluation.*note: this article reports product extrusion and too short of an implant as reasons for revisions.Both of these reported reasons are being filed as separate mdr's, both with the same reference number, (b)(4).
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Event Description
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Results reported in the literature article ¿transcanal endoscopic ear surgery for middle ear cholesteatoma¿, glikson, e., et al, otology <(>&<)> neurotology, vol.38, no.Xx, 2017, indicate that out of 123 total ossicular chain reconstruction procedures, 29 patients required revisions due to displaced or extruded prosthesis.The objective of the research:¿ossicular chain disruption in children leads to conductive hearing loss.Few studies have focused on factors influencing successful results in pediatric ossicular chain reconstruction (ocr).We aim to determine whether demographic or surgical factors affect hearing outcomes in pediatric ocr.¿ the authors confirm that ¿all revision cases were completed to improve hearing outcomes.".
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Correct title of journal article: ¿factors influencing hearing outcomes in pediatric patients undergoing ossicular chain reconstruction¿, n.Govil, et al.; international journal of pediatric otorhinolaryngology 99 (2017) 60-65.Http://dx.Doi.Org/10.1016/j.Ijporl.2017.05.022.
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Search Alerts/Recalls
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