The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part: 412.216s, lot: 1l68285, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: oct 01, 2018, expiry date: sep 01, 2028.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 412.216, lot number: 1l43781, manufacturing site: (b)(4), release to warehouse date: sep 17, 2018.A manufacturing record evaluation was performed for the non-sterile device lot number, and no non-conformance were identified.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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Device report from (b)(6) reports an event as follows: it was reported that on an unknown date, the patients suffered from a medial colum fracture of the femur.All healed well.But he developed irritations caused by the implant under the soft tissue.So, implant removal was planned.No comorbidities.The surgery was completed successfully without delay.There was no patient consequence.This complaint involves four (4) devices.This report is for (1) 5.0mm ti locking scr slf-tpng w/t25 stardrive 44mm-sterile.This report is 1 of 4 for (b)(4).Related product complaint: (b)(4).
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