Product complaint # (b)(4).510k: this report is for an unk - constructs: veptr/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 product was received; no conclusion could be drawn at the time of filing this report.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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Device report from synthes reports an event in canada as follows: this report is being filed after the review of the following journal article: el-hawary, r.Et al (2020), veptr treatment of early onset scoliosis in children without rib abnormalities: long-term results of a prospective, multicenter study, journal of pediatric orthopedics, vol.40 (6), pages e406¿e412 (canada).The aim of this multicenter, observational, prospective study is to hypothesize that long-term (ie, 5 y) veptr treatment of eos without rib abnormalities similarly prevents scoliosis progression and allows spinal growth.Between january 2007 to january 2015, a total of 59 patients (33 male and 26 female) with a mean age of 6.1±2.4 years were included in the study.Surgery was performed using a vertical expandable prosthetic titanium rib (veptr); depuy synthes spine, raynham, ma.The mean follow-up was 6.9±1.4 years.The following complications were reported as follows: 2 patients died.11 patients had converted to other growth-friendly devices.3 patients had veptr explanted.Although secondary scoliosis curve improved immediately after veptr implantation (39±20 to 33±20 degrees), recurrence was observed to a comparable magnitude as preoperatively (42±19 degrees).In 18% of patients, the major curve was deteriorated at the last overall follow-up.In 51% of patients, the minor curve was deteriorated at the last overall follow-up.In 50% of patients, the maximum kyphosis was deteriorated at the last overall follow-up.In 4% of patients, the t1-t12 height was deteriorated at the last overall follow-up.In 12% of patients, the t1-t12 sagittal length was deteriorated at the last overall follow-up.In 12% of patients, the t1-s1 sagittal length was deteriorated at the last overall follow-up.In 21% of patients, the composite success (major curve, t1-t12, and t1-s1 heights) was deteriorated at the last overall follow-up.42 patients (71%) experienced at least 1 complication, with 105 total complications observed (table 6).Among these, 68 were device-related and 32 were disease related (table 7).16 patients had spine infection.9 patients had wound dehiscence.8 patients had implant failure.8 patients had pain.7 patients had pneumonia.6 patients had other wound complication.5 patients had other medical illness.5 patients had other respiratory illness.4 patients had prominent implant.3 patients had other fracture.2 patients had abdominal injury.2 patients had neurological injury.2 patients had rib fracture.1 patient had cardiac arrest.1 patient had pneumothorax.24 patients had device migration.This report is for an unknown synthes veptr constructs.This report is for (1) unk - constructs: veptr.This is report 1 of 2 (b)(4).
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