(b)(4) initial report the appropriate device details have been provided and the relevant device manufacturing records will be retrieved and reviewed.The explanted devices have been returned to corin and will be examined.The results of this will be provided in a supplemental report upon completion of the investigation.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
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(b)(4) final report.Operative notes, patient x-rays and the explanted devices were provided to aid the investigation and were reviewed at corin.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed.It was found that all parts associated with these records conformed to material and dimensional specification when manufactured.The explanted devices were returned for examination.The examination of the returned explants could not identify a specific reason for revision, any obvious failure modes or abnormal device characteristics.The corin devices were coupled with a taper conversion sleeve (manufacturer unknown), which exhibited evidence or corrosion inside it.Based on this, it cannot be determined whether the corin cormet devices caused or contributed to the patients experience and corin now considers this case closed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
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