This report is for unknown biomaterial cement: norian: trauma.Part and lot numbers are unknown.Without the specific part and lot number; the udi number is not available.Complainant device is not expected to be returned for manufacturer review/investigation.The (510k#): unknown.Reporter phone number is not provided for reporting.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.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.[(b)(4) hanke et al.11jan2018.Pdf].
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This report is being filled after the subsequent review of the following literature article hanke a., baumlein m., lang s., gueorguiev b., nerlich m., perren t., rillmann p., ryf c., miclau t., loibl m.(2017).Long-term radiographic appearance of calcium-phosphate synthetic bone graft after surgical treatment of tibial plateau fractures.Injury, int.J.Care injured.48:2807-2813.Switzerland.The purpose of this study to assess the long-term resorbtion of two different cap synthetic bone graft products used for operative treatment of treatment of tibial plateau fractures by comparing their radiographic visibility in a long-term follow-up.The study included 38 patients, 21 females and 17 males, all with intraarticular tibial plateau fractures.Nineteen (19) of the patients were inserted with sbg type a (chronos inject, depuy sysnthes, oberdorf, switzerland), and the remaining nineteen (19) were inserted with sbg type b (norian srs, depuy synthes, oberdorf, swizerland).Two patients (one with the sbg a and the other with sbg b) experienced early wound infections in the first month following the surgery.The hardware was not removed in either case.Twenty-nine (29%) percent of the patients with sbg b experienced no resorbtion (resorbtion of the sbg is a needed part of the healing process), 17.5% experienced more than 50% resorbtion, 52.6% experienced less than 50% resorption.No patient with the sbg b experienced complete resorbtion.Of the patients inserted with sbg a 21.1% experienced more than 50% resorbed and 7.0% experienced less than 50% resorbed.The remaining 71.9% experienced complete resorbtion.Four patients ( 2 in the sbg a group and 2 in the sbg b group) had a subsidence greater than 2 mm.One patient declared moderate pain and reduced knee scores.Three patients were asymptomatic.Four (4) patients who experienced a subsidence greater than 2 mm were: 1 female patient (b)(6) (sbg a), 1 female patient (b)(6) (sbg a), 1 female patient (b)(6) (sbg b), 1 male patient (b)(6) (sbg b).This report is for the patients with the sbg b, who experienced incomplete or no resorbtion following the surgery.This report is for unknown biomaterial cement: norian: trauma.This is report 3 of 8 for complaint (b)(4).
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