This report is for an unknown veptr implants/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.
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This report is being filed after the review of the following journal article: verhofste b.,et al (2020)spinal deformity in sotos syndrome: first results of growth-friendly spine surgery, j pediatr orthop volume 40, number 9,pages 1-9 (usa)doi: 10.1097/bpo.0000000000001554.This case-series aims to describe the presentation of spinal deformity in patients with ss and eos; and to report the long-term outcomes and complications of gfi in these patients.A total of thirteen patients (9 males, 3 females) with a mean of 3.7 ±2.30 years old (range, 0.4 to 7.5 y) at presentation diagnosed with ss and eos were identified from two multicenter eos databases (1997-2017) and were included in the study.Patients received gfi for the treatment.All procedures were performed through a posterior approach.Eight patients were treated with tgr , 2 received mcgr ,and 2 veptr were inserted, and 1 psf.Mean age at index surgery and follow-up duration were 5.0 years (range, 1.8 to 10 y) and 7.2 years (range, 2.1 to 14.9 y), respectively.The following complications were reported as follows: six patients experienced a rod fracture: 3 patients developed 1 rod fracture and 3 patients fractured a rod on 2 separate occasions.A case of a (b)(6) year old male (patient 10) had pneumonia (nonop) and underwent 1 revision.A case of a (b)(6) year old male (patient 11) had rod fracture (unplanned) and underwent revisions 3 times.This report is for an unknown synthes veptr implants.It captures the reported events of six patients who experienced the rod fractures.This is report 2 of 3 for (b)(4).
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