510k: this report is for an unknown screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Patient code (b)(4) no code available used to capture need for surgical intervention 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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This report is being filed after the subsequent review of the following salim r., fogagnolo f., perina m.M., rubio m.U., junior k.M.(2017).Conventional plate and screws in medial opening-wedge high tibial osteotomy: are they sufficiently stable? a retrospective study.Revista brasileira de ortopedia,52(5): p.549-554.Brazil.Conventional plate and screws in medial opening-wedge high tibial osteotomy: are they sufficiently stable? a retrospective study.The purpose of the study was to assess the maintenance of the correction achieved in cases wherein fixation was performed using conventional implants.The study included 51 patients ranging between the ages of 18 and 62, the mean age being 48.8 years old.Of the 51 patients 31 were males and 20 were females.Each patient underwent medial opening wedge high tibial osteotomy as treatment for varus deformity in the proximal end of the tibia, and was implanted with a 4.5 dcp plate, spongious screws and cortical screws (synthes, (b)(4)).Following the initial surgery 9 patients had to undergo autogenous bone grafting harvested from iliac crest.Three (3) patients exhibited fixation failure with loosening of implants and loss of correction.One (1) patient had a hematoma in the surgical site that required surgical drainage and that subsequently resolved.A copy of the literature article is being submitted with this medwatch.This report is for unknown screws this is report 2 of 2 for (b)(4).
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