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This report is being filed after the review of the following journal article: rosen, charles l.(2011), results of the prospective, randomized, multicenter clinical trial evaluating a biosynthesized cellulose graft for repair of dural defects / neurosurgery, volume 69, issue 5, 1 november 2011, pages 1093¿1104.(usa) the purpose of the study was to report the 6-month results of a randomized, controlled trial of a biosynthesized cellulose (bsc) duraplasty device compared with commercially available dural replacement implants.Between february 2006 and january 2009, 99 patients were treated, 62 in the bsc group (onlay, 34 patients; substitute, 28 patients) and 37 in the control group.The bsc device, synthes synthecel dura replacement had 2 forms: substitute and onlay.Physical examinations were performed pre- and postoperatively within 10 days and at 1, 3, and 6 months.Magnetic resonance imaging (mri) was performed preoperatively and at 6 months.The primary study endpoint was the absence of pseudomeningocele and extracerebral fluid collection confirmed radiographically and the absence of cerebrospinal fluid fistula at 6 months.The following complications were reported: 2 patients in the bsc group presented with pseudomeningocele (with extracerebral fluid collection) that occurred after supratentorial benign/low-grade tumor removal; neither patient required further intervention.2 cases of pseudomeningocele and extracerebral fluid collection, 5 cases of abnormal thickening along the graft site, 1 case of brain edema adjacent to graft site and 1 case of enhancement of left internal auditory canal were reported in the bsc group.There was one case of pseudomeningocele and extracerebral fluid collection.1 patient in the bsc group had abnormal thickening along the graft site reported.The incidental findings of thickening were characterized as within the range of the normal healing process, and no additional treatments were deemed necessary.Three bsc patients exhibited a superficial site infection.A deep site infection developed in 1 patient (1.6%) implanted with bsc during the short-term follow-up (10-30 days).2 cases of a superficial surgical site wound infection involved a suture abscess that required antibiotic treatment.The third superficial surgical site infection was not confirmed; the incision was tender but was treated with a course of antibiotics.The deep surgical site infection presented with slight dehiscence in the superficial part of the scalp incision with some questionable purulent drainage.No redness appeared around the incision; no fever was present.It was consistent with a vicryl stitch abscess.The wound was cultured (cultures were negative for bacteria), the patient was brought into the operating room for irrigation and washout of wound infection and revision of wound and placed on empirical antibiotics.The graft was not removed.1 patient in the bsc group had benign/low-grade tumor, and a parasagittal surgical approach was used.At the 1-month follow-up visit, magnetic resonance imaging showed a right parietal fluid collection.A course of steroid therapy was administered, and the hematoma/seroma resolved 3 weeks later.Two patients implanted with bsc required further surgery, after partial tumor resections.The first patient underwent a complete resection of a grade ii astrocytoma that had increased in size.The second patient required a complete resection of a grade ii pleomorphic xanthoastrocytoma.2 patients had brain edema, 3 had csf leak, 1 had diplopia , 10 had dizziness, 30 had headache,2 had hydrocephalus, 1 had infection: surgical site deep, 3 had infection: surgical site superficial, 63 had neurologic events , 7 had pain at incision, 6 had paresthesia, 1 had a seizure, 3 had seroma, 2 had a stroke, 1 subdural hematoma, 3 had surgery: reoperation (index site).3 patients had anemia, 6 had cardiovascular events, 8 had dermatologic events, 14 had drug reactions,15 had edema, 9 had fatigue, 5 had fever , 27 had gastrointestinal , 1 had genitourinary, 2 had hematoma, 1 had hemorrhage, 2 had hoarseness, 4 had infection: other, 5 had insomnia, 11 had musculoskeletal events, 16 had pain, 3 had pruritus, 6 had psychological, 6 had respiratory events, 1 had a sore throat, 2 had surgery: other , 1 had thrombosis, 2 had urinary tract infection wound issues: other.2 cases of poor device strength were recorded under bsc group (substitute).3 cases of fair device suturability was recorded under bsc group (substitute).1 case of poor device seal quality under bsc (onlay) was recorded.7 cases of fair device seal quality under onlay and 2 cases under substitute.This report is for unknown synthes synthecel dura replacement implants.This is report 2 of 2 for (b)(4).
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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.H11: b1, b2, b5, h1: the initial complaint was reviewed and found not reportable.The adverse events were reported to the fda through the ide pathway.At the time when the study was completed it was not required to report ide adverse events to the chu since the product was not being commercialized at that time.The article was submitted to the chu since it is the ide study and no new adverse event information is contained in the article.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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