Product complaint # (b)(4).This report is for an unk - plates: tomofix osteotomy /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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
|
Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: wang x., et al (2021) salvage of severe knee osteoarthritis: efficacy of tibial condylar valgus osteotomy versus open wedge high tibial osteotomy, journal of orthopedic surgery and research volume 16: pages 1-11 (china).This retrospective study aims to present a comprehensive comparison between two types of osteotomy in terms of radiological assessment and clinical evaluations, and it also shed new insight on the indication criteria for tcvo.September 2015 to october 2018, patients who received osteotomy were evaluated.A total of 63 oa knees from 46 cases, with complete medical records and a minimum follow-up of 26 months, were included in the study.Thirty-four oa knees from 22 cases (10 males,12 females) age 56 (40¿74 years) with lateral joint dilation (jlca over 4°) and depression of the medial tibial plateau (mtpd less than - 4°) underwent tibial condylar valgus osteotomy (tcvo) surgery.Open-wedge high tibial osteotomy (owhto) was performed on the rest 24 cases (12 males, 12 females) 29 oa knees with age 59 (43¿75 years).In owhto procedure a tomofix¿ plate with interlocking screws was used for internal fixation of the osteotomy site while in the tcvo procedure the anteromedial aspect of the tibia was fixed by a t-shaped locking plate or a tomofixtm locking plate and stabilized with locking screws.For comparing the outcomes of these surgical procedures during severe varus deformity, 27 knees with a pre-operative fta = 185° were defined as those with severe varus (subgroup s, 15 knees in 9 cases (3 males and 6 females ) age 57 (45¿68 years ) in stcvo group and 12knees in 10 cases (4 males, 6 females) age 61 (51¿71 years) in shto group).Tcvo was followed up at 35 (27¿42) months and hto group at 33 (27-65) months.The following complications were reported: mtpd increased to 5.9 ± 2.5° (p < 0.05) in tcvo group.Increased in terms of limb alignment, %ma in tcvo group.Under corrected knees 13.3% in tcvo group.Opening angle and distance of the opening gap were larger in tcvo group (19.1° and 14.0 mm).One skin irritation in owhto group.Mtpd was relatively the same before and after owhto.Increased in terms of limb alignment, %ma in owhto group.Higher rate of under corrected knees (post-operative fta over 175°) was observed in the shto.This report is for an unknown synthes tomofix¿ plate with interlocking screws and tomofixtm locking plate and stabilized with locking screws.This report is for (1) unk - plates: tomofix osteotomy this report is 1 of 4 for (b)(4).
|