Device Problem
Device Slipped (1584)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown mono/polyaxial screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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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Event Description
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This report is being filed after the review of the following journal article: hofmann, a, et al.(2020), treatment of severe kyphoscoliosis in children with mucopolysaccharidosis type i (pfaundlerehurler syndrome) using the growing rod technique: a case series with mid-term results, world neurosurg, volume 139, pages 169-174, (germany).This retrospective study presents 3 cases of children with mucopolysaccharidosis type i (mps i) with thoracolumbar kyphosis/ kyphoscoliosis treated with a growing rod system.Between 2007 and 2019, 3 cases of surgically treated children with kyphoscoliosis and mps i were included in the study.All patients had a progressive and clinically apparent kyphosis of the thoracolumbar or upper lumbar spine and had exhausted conservative treatment.Conservative treatment was controlled frequently with plain radiographs.The angle of kyphosis was measured using the cobb method.Surgery was performed using the unknown depuy spine expedium 4.5 pedicle screw system in 1 case and the unknown synthes synapse system in 2 cases based on the patients¿ anatomic preconditions and age.For distraction, the distraction connectors for unknown depuy spine 5.5-mm rods were used.The mean duration of surgery was approximately 3 hours.Intraoperative neuromonitoring was performed.Follow-up care included an individual orthosis (with period depending on postoperative x-ray) and physical therapy for 3 months.During postoperative follow-up, medical history, patient satisfaction, pain (on a visual analog scale), and walking distance were evaluated at 1, 3, 6, and 12 months.Follow-up was done at least 2 to 4 times per year since then.Annual total spine radiographs were obtained each year with a minimum follow-up time of 6 years.Complications were reported as follows: case 2, a (b)(6) year-old boy (year of birth (b)(6)) had an increasing right-convex lumbar scoliosis below the stabilization with the apex at l4 (28 degrees), pectus excavatum, and nanism during follow up in 2014 at age (b)(6) years.Surgery was indicated with complete removal of material and re-instrumentation from t10 to l5.Surgical correction of the pectus excavatum was done with implantation of a steel bar according to the nuss procedure, which is scheduled for removal at age (b)(6).Two other distractions of the lumbar stabilization were done in january 2015 and november 2015 without any complications.Case 3, a (b)(6) year-old girl (year of birth (b)(6)) had further distractions done in 2015 with exchange of the l4 screws because of loosening and in 2016 without any complications.The patient was able to walk at any time without relevant pain and adjuvants.No additional distraction is intended.Final correction and fusion are outstanding at present.This report is for the unknown depuy spine expedium 4.5 pedicle screw system and 5.5-mm rods.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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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Event Description
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This report is for one (1) unk - constructs: expedium.
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Search Alerts/Recalls
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