This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 431 patients (432 procedures) who were operated with depuy synthes implants against all other alif procedures recorded within the spine tango registry from august 18, 2005 to march 14, 2019.There were 276 females and 156 males with a mean age of 59 years.Since it was not specified in which country the adverse events have occurred, each country mentioned in the surgery activity namely: switzerland, belgium, italy, poland, australia and united kingdom will be conservatively captured in separate product complaints: intraoperative surgical complications: (n=1) nerve root damage, (n=3) dural lesion, (n=4) vascular injury, (n=8) other, (n=8) unknown.Intraoperative general complications: (n=1) not documented, (n=8) unknown.Postoperative general complications: (n=1) cardiovascular, (n=1) pulmonary, (n=1) liver/gi, (n=7) not documented, (n=1) other, (n=8) unknown.Postoperative surgical complications: (n=6) other hematoma, (n=1) radiculopathy, (n=2) motor dysfunction, (n=1) sensory dysfunction, (n=2) implant failure, (n=7) not documented, (n=8) unknown, (n=1) implant malposition.Postoperative complications: (n=5) sensory dysfunction, (n=5) motor dysfunction, (n=2) bowel/bladder dysfunction, (n=1) non-union, (n=5) implant failure, (n=3) instability, (n=7) wound infection superficial, (n=1) wound infection deep, (n-=1) epidural hematoma, (n=1) extravertebral hematoma, (n=6) recurrence of symptoms, (n=3) adjacent segment pathology, (n=1) decompensation of spine, (n=3) fracture vertebral structures, (n=1) thromboembolism, (n=11) other, (n=1) implant malposition.Reoperations at any level: (n=5) hardware removal, (n=2) non-union, (n=5) instability, (n=2) failure to reach therapeutic goals, (n=1) postop deep infection, (n=5) implant failure, (n=2) adjacent segment pathology, (n=3) other, (n=16) unknown.Reoperations at same level: (n=3) hardware removal, (n=3) instability, (n=2) failure to reach therapeutic goals, (n=1) postop deep infection, (n=2) implant failure, (n=2) adjacent segment pathology, (n=2) other, (n=4) unknown.This is for the unknown depuy synthes spine syncage, unknown depuy synthes spine syncage evolution, unknown depuy synthes spine synfix lr, unknown depuy synthes spine synfix evolution, unknown depuy synthes spine synex, unknown depuy synthes spine t-pal, unknown depuy synthes spine oracle, unknown depuy synthes spine tslp, unknown depuy synthes spine atb plate, unknown depuy synthes spine cslp, unknown depuy synthes spine uss, unknown depuy synthes spine chronos, unknown depuy synthes spine chronos putty, unknown depuy synthes spine vertecem, unknown depuy synthes spine vertecem v+, unknown depuy synthes spine matrix, unknown depuy synthes spine travios., unknown depuy synthes spine peek rod.A copy of the clinical evaluation form is being submitted with this regulatory report.This report is for one (1) unk: rods: spine.This is report 3 of 14 for complaint (b)(4).
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