Device report from synthes reports an event in (b)(6) as follows: the current report is a retrospective analysis of patients, prospectively collected in the swespine registry, who underwent instrumentation with expedium posterior for the period identified between january 02, 2006, and november 22, 2020.Indications for instrumentation were with 3007 cases (2997 female): 1051 were isthmic spondylolysis/-lithiasis and 1956 were ddd and related conditions with a mean age of 51 years.2677 cases (2673 females) were with lumbar spinal stenosis (lss) with a mean age of 64 years.148 cases (146 females) were with degenerative cervico-thoracic spine with a mean age of 64 years.1837 patients were with deformities, with a mean age of 22 years.For meaningful analysis, the cohort was divided into two samples: study sample 1 was restricted to age < 25 years with no previous spine surgery; n = 1316 with a mean age of 15.5 years, and study sample 2 includes patients from age 25 years.N = 329 with mean age of 52 years, females were 71% (available data =324).83 patients had earlier spine surgery.817 cases (782 females) were with metastatic malignancy.33 patients had additional anterior instrumentation with non-depuy devices and 1 patient with cslp.The non-depuy devices were excluded, leaving 784 cases for analysis mean age of the patients was 66years.34% females.And, 141 patients were with infection, 19 were excluded in the analysis, leaving 121 cases with expedium posterior solo.3007 cases (2997 female) : 1051 were isthmic spondylolysis/-lithiasis and 1956 were ddd and related conditions; 2677 cases (2673 females) were with lumbar spinal stenosis (lss); 148 degenerative cervico-thoracic spines; 1316 with deformity (group 1); 329 with deformity (group 2); 784 with metastatic malignancy; 121 with infection.Registered intra-operative complications: 74 /1051 dural tear, 7/1051 root injury, 14/2677 dural tear, 7/148 dural tear, 1/148 horner syndrome, 2/148 recurrent injury, 2/148 oesophagus injury, 1/148 root injury, 7/1316 dural tear, 2/1316 medullary injury, 1//1316 root injury, 36/1316 others, 49/ 329 dural tear, 2/ 329 medullary injury, 2/ 329 root injury, 15/ 329 other, 18 /784 dural tear, 3/784 medullary injury, 2/784 root injury, 1/121 dural injury, 5/121 medullary injury, 2/121 other.2/ 1051 death.5 /1316 death.9/784 death.38/1051 misplaced implant.21/2677 misplaced implant.4/148 misplaced implant.12/784 misplaced implant.8/121 misplaced implant.Reinterventions during index stay: 3/1051 drain infection, 1 /1051 redecompression, 7/1051 removal implant, 4/1051 repair dural injury, 36/1051 adjustment implant, 3/1051 stop bleeding, 12/1051 other, 21/2677 adjustment implant, 1/2677 drain hematoma, 7/2677 drain infection, 3/2677 redecompression, 3/2677 removal implant, 14/2677 repair dural injury, 12/2677 stop bleeding, 9/2677 other, 1 /148 drainage hematoma, 1/148 removal implant, 5 /1316 adjustment implant, 1 /1316 drain deep infection, 5 /1316 removal implant, 5/ 329 adjustment implant, 3/ 329 drain infection, 2/ 329 removal implant, 1/ 329 repair dural injury, 1/ 329 other.Registered post-op complications within 1 year: 12 /1051 pulmonary embolism, 42 /1051 ssi, deep, 156/1051 ssi, superficial, 14/1051 thromboembolism, 9/2677 venus thrombosis, 12/2677 pulmonary embolism, 39/2677 ssi deep, 151/2677 ssi superficial, 1 /148 ssi deep, 7/148 ssi superficial, 4/148 venous thrombosis, 20/121 ssi superficial, 2/121venous thrombosis.Readmissions 1: 1 /1051 drain hematoma, 20 /1051 drain infection, 86 /1051 refusion, 94/1051 removal implant, 4 /1051repair dural injury, 4/1051revision of fusion, 34/1051 other, 3/2677 drain hematoma, 16/2677 drain infection, 19/2677 redecompression, 29/2677 refusion, 47/2677 removal implant, 2/2677 repair dural injury, 5/2677 revision of fusion, 18/2677 other, 3/148 drain deep infection, 1/148 refusion, 1/148 removal implant, 9/1316 drain hematoma, 9/1316 drain infection, 10/1316 removal implant, 9/1316 revision of fusion, 1/329 drain hematoma, 5/ 329 drain infection, 4/ 329 removal implant, 2/ 329 revision of fusion, 5/ 329 other, 22 /784 drain infection, 3 /784 redecompression, 3 /784 removal implant, 1/784 repair dural injury, 3 /784 stop bleeding, 1/121 drain infection, 2/121 removal implant, 2/121 other.Readmissions 2: 6/1051 drain infection, 24/1051refusion, 14/1051 removal implant, 2 /1051 repair dural injury, 7 /1051 other, 5/2677 drain infection, 3/2677 redecompression, 4/2677 refusion, 7/2677 removal implant, 1/2677 repair dural injury, 2 /2677 other, 2/148 drain deep infection, 1 /148 redecompression, 1/1316 drain infection, 2 /1316 removal implant, 7 /1316 other, 2/ 329 drain infection, 8/ 329 removal implant, 6/ 329 revision of fusion, 7/ 329 other, 1 /784 drain hematoma, 3 /784 drain infection, 1 /784 redecompression, 1 /121 removal of implant, 2 /121 other.Readmission 3: 5/1051 refusion, 3/1051 removal implant, 3 /1051 other, 4 /2677 drain infection, 2/2677 removal implant, 7/1316 other, 5/ 329 drain infection, 1/ 329 removal implant, 4/ 329 revision of fusion, 5/ 329 other, readmission 4: 1 /1051 refusion, 2 /1051 removal of implant, 1 /1051 other, 1/2677 drain infection, 1/2677 removal of implant, 1/2677 other, 1/1316 removal of anterior implant, 1/ 329 removal implant, 6/ 329 other.Readmission 5: 1 /1051 other, 1/2677 drain infection, 1/ 329 drain infection, 1/ 329 other.1051 patient with expedium posterior - ddd + isthmic spondylolisthesis: global assessment of back pain failure% fu 1 yr.40% fu 2 yrs.40% fu 5 yrs.38%; global assessment of leg pain (ga) failure% fu 1 yr.39% fu 2 yrs.40% fu 5 yrs.37% 2677 patient with expedium posterior - lumbar spinal stenosis global assessment of back pain failure% fu 1 yr.40% fu 2 yrs.42% fu 5 yrs.46%; global assessment of leg pain (ga) failure% fu 1 yr.34% fu 2 yrs.36% fu 5 yrs.36% 148 patients with expedium posterior - degenerative cervico-thoracic spine global assessment of back pain failure% fu 1 yr.72% fu 2 yrs.58% fu 5 yrs.74%; global assessment of leg pain (ga) failure% fu 1 yr.76% fu 2 yrs.77% fu 5 yrs.93%.784 patient with expedium posterior - metastatic malignancy (proms) pain : worse (n-100) and unchanged (n=24).Readmission 1: 30/1051 adjustment implant, 13/2677 adjustment implant, 1/148 adjustment implant, 14 /1316 adjustment implant, 1/ 329 adjustment implant, 6 /784 adjustment implant.Readmission 2: 4/1051 adjustment implant, 2 /2677 adjustment implant, 4 /1316 adjustment implant, 10 / 329 adjustment implant, 1 /784 adjustment implant.Readmission 3: 1/1051 adjustment implant, 1/2677 adjustment implant, 2/1316 adjustment implant, 1/ 329 adjustment implant.Readmission 4: 3 / 329 adjustment implant.Readmission 5 1 / 329 adjustment implant.This is for depuy spine expedium.This report is for one (1) unk - constructs: expedium.This is report 1 of 4 for complaint (b)(4).
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