This report is for an unknown constructs: plate/screws-craniofacial/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.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.(b)(4).
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This report is being filed after the review of the following journal article: mccann, a.C.Et al.(2018), comparison of modern rigid fixation plating outcomes for segmental mandibular microvascular reconstruction, laryngoscope, vol.129, pages 1081-1086 (usa) doi: 10.1002/lary.27406.The aim of this study was to assess and compare the outcomes of both of these new technologies when utilized for mandibular microvascular reconstruction.Between july 1, 2011, and july 1, 2016, a total of 142 patients (101 males and 41 females) with age ranged from 14 to 92 years old (average age of 61 years) who underwent osteocutaneous microvascular reconstruction of the mandible were included in the study.Subjects were stratified into two groups based on the technique of rigid fixation: 1) preformed/ prebent reconstruction plates and 2) cad/cam custom plates.Implants used were both synthes (west chester, pa) and kls martin (jacksonville, fl) for cad/cam custom plates as well as both synthes (west chester, pa) and kls martin (jacksonville, fl) for preformed/prebent plates.Mean follow-up time was 16 months, with a range of 6 to 72 months.The article did not specify which of the devices were being used to capture the following complications: for patients receiving preformed/prebent plates, 38% of fibular flaps and 34% of radius flaps experienced plate-related complications; of these, 21% of fibular flaps required reoperation versus 18% of radius flaps.For patients receiving custom cad/cam plates, 38% of fibular flaps and 34% of radius flaps had plate-related complications; of these, none of the fibular flaps and 3 of the radius flaps required reoperation among the 89 subjects who received preformed plates for their reconstruction, 32 experienced plate-related complications.In the cad/cam group, 11 of the 53 subjects had complications.Of the patients receiving preformed plates who had perioperative complications,18 required reoperations.For the 11 patients with cad/cam plates who had plate-related complications, 3 required reoperation for mandibular defect length, the average defect size in the preformed/prebent plating group was 7 cm, with a standard deviation of 2.4 cm and a range of 2.5 to 14 cm.In the custom cad/cam plating group, this had an average defect length of 8.1 cm, standard deviation of 2.9 cm, and a range of 4 to 16 cm this report is for an unknown synthes cad/cam custom plates and preformed/prebent plates.This is report 1 of 1 for (b)(4).
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