This report is being filed after subsequent review of the following journal article, a case review was performed of 8 patients who had undergone rhbmp-2 bone grafting using porous polyethylene as the containment device.Eight maxillary and two mandibular alveolar defects were grafted using rhbmp-2 and titanium-reinforced porous polyethylene as a soft tissue barrier.One patient received autologous ramus bone in addition to the rhbmp-2.All patients were followed up by clinical examination and periodic radiographic studies for 6 months to 2 years.Implant-borne prostheses were fabricated on all successful grafts.A (b)(6) man three months postoperatively, a wound dehiscence developed, and the barrier was exposed at the crest of the ridge.At 6 months postoperatively, the membrane was removed.The grafted region of the alveolus was found to have successfully gained width, but the vertical component of the graft was not successful.Of the 10 grafted alveolar defects, 2 (20 percent) resulted in early exposure of the containment devices, were removed, and resulted in no bone formation.One of the 10 defects (10 percent ) became exposed 3 months postoperatively and resulted in only moderate bone formation.In the 7 nonexposed cases (70percent), bone formation was excellent, and implants were successfully placed.This is 3 or 4 reports for (b)(4).This report is for an unknown synpor.A copy of the literature article is being submitted with this medwatch.
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This device is used for treatment not diagnosis reconstruction of alveolar defects using titanium-reinforced porous polyethylene as a containment device for recombinant human bone morphogenetic protein 2 hart.K, bowles.D, american association of oral and maxillofacial surgeons.J oral maxillofac surg 70:811-820, 2012.This report is for an unknown synpor.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or 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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