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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Tissue Damage (2104); Impaired Healing (2378); Reaction (2414)
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Event Type
Injury
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Event Description
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This report is being filed after the subsequent review of the following literature article; (may 31, 2005) the treatment of spine and chest wall deformities with fused ribs by expansion thoracotomy and insertion of vertical expandable prosthetic titanium rib.Emans; issue: volume 30(17s) supplement, 1 september 2005, pp s58-s68 this article reports complications that were reported in studies and prospective clinical trial of vertical expandable prosthetic titanium rib (veptr) in patients with combined spine and chest wall deformity with scoliosis and fused ribs.Also, report the efficacy and safety of expansion thoracostomy and veptr surgery in the treatment of thoracic insufficiency syndrome (tis) associated with fused ribs.The results reported concerning thirty-one patients with fused ribs and tis were treated, 4 of whom had undergone prior spinal arthrodesis at other institutions with continued progression of deformity.In 30 patients, the spinal deformity was controlled and growth continued in the thoracic spine during treatment at rates similar to normals.Increased volume of the constricted hemithorax and total lung volumes obtained during expansion thoracostomy were maintained at follow-up.Technique related complications included: patient 4-(id (b)(6)) was (b)(6) years at the time of the event.Patient 1¿s primary diagnosis was deformity diagnosis fused ribs and thoracogenic scoliosis, veptr construct at 2 rib-to-rib with no device migrations.Patient has had multiple prior incisions, direct trauma and prior history of chest wall infections with partial dehiscence of thin skin with no muscle over a prominent device may have contributed to a deep postoperative infection noted 3 weeks after surgery.Both devices were removed and could not be re-implanted because of inadequate soft tissue coverage.Spinal fusion was eventually performed.The procedure related complications include surgical site deep wound infection requiring removal of both devices and spine fusion performed later.This report is for 3 of 18 for (b)(4).This part data for unknown veptr, unknown quantity, part and lot number.A copy of the literature article is being submitted with this medwatch.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Emas (may 31, 2005): the treatment of spine and chest wall deformities with fused ribs by expansion thoracotomy and insertion of vertical expandable prosthetic titanium rib.Emans; issue: volume 30(17s) supplement, 1 september 2005, pp s58-s68 this report is for unknown veptr implant, unknown quantity, unknown item number, unknown initial reporter phone number: (b)(6).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot and part number was provided.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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Search Alerts/Recalls
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