Implantation date unknown.510k: this report is for an unk - constructs: matrix /unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.(b)(4).
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Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: melich g, et al.(2014), total sacrectomy for recurrent rectal cancer ¿ a case report featuring technical details and potential pitfalls, international journal of surgery case reports, volume 5, page 403-407, (canada).This study presents the first case report describing technical aspects, potential pitfalls and treatment of complications associated with total sacrectomy performed as a treatment of recurrent rectal cancer.This is a case report on a (b)(6) year-old man previously treated with a low anterior resection (lar) followed by chemo-radiation and left liver tri-segmentectomy for metastatic rectal cancer.3 years following the lar, the patient developed a recurrence at the site of colorectal anastomosis, manifesting clinically as a contained perforation, forming a recto-cutaneous fistula through the sacrum.The patient then underwent abdomino-perineal resection (apr) and complete sacrectomy.An unknown synthes matrix spine system was used during the spino-pelvic reconstruction and stabilization.Following 48 hours hemodynamic stabilization in the intensive care unit, the sacrum was removed from the pelvis en bloc together with the rectum.There was more than 4000 ml of estimated bloodloss.The stabilization of the spine to the pelvis was completed by placing 2 large unknown synthes synmesh cylindrical cages which were impacted into the inferior end plate of l5 and secured to the ilium bilaterally with large fragment cortical screws.Previously harvested iliac crest bone graft was mixed with 1 gram of vancomycin and placed within the cage to facilitate fusion.5 weeks after the operation, the patient suddenly became hemodynamically labile and blood started pouring out of the perineal wound.He had cardiac arrest while he was being actively resuscitated which lasted for 9 minutes.Cardiopulmonary resuscitation was performed to re-establish cardiac activity.A ruptured pseudoaneurysm of the right iliac artery was shown during an emergency ct-angiography.The right iliac artery was stented in the angio suite with subsequent arrest of the bleeding.The next day, the patient underwent evacuation of the hematoma because of the compressive symptoms caused by the large collection of blood in the abdomen.45 days after the event, the patient was found to have blood leaking from the wound in the perineum while doing some physiotherapy.An urgent angiogram showed a ruptured pseudo-aneurysm from the previously clipped left internal iliac artery.The artery was stented, and the bleeding stopped immediately.1 year after the resection, the patient remains disease free.His bladder dysfunction is managed by an indwelling catheter.He ambulates primarily by wheelchair although his lower leg strength has progressed to the point where he is able to bend his knees and lift his legs at the hips against gravity, which allows him to assist with transfers.This report is for the unknown synthes matrix spine system and unknown synthes synmesh cylindrical cages.This is report 1 of 2 for (b)(4).
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