(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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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This report is being filed after the subsequent review of the following literature article: 4,5 year infection rate in open spondylodesis with decompression versus the less invasive lis technique in lumbar spine.Authors: pfandlsteiner t., wimmer c.Source: european spine journal.2010 nov; conference: 5th german spine conference- annual meeting of the german spine society.Bremen germany.Conference publication: (var.Pagings).19 (11) :1978.Deep infection (ae only ¿ expedium system) - unknown patients with open mono stabilizations, bi stabilizations, poly-segmental stabilizations and open stabilization (2006-2010); deep infection was evaluated.In all deep infections wide debridement, jet lavage, drainage was done, parenteral antibiotics 7 to 10 days by antibiogramm and afterwards oral antibiotics were given.In deep infections in 3 cases s.Aureus, in 4 cases mrse, in 2 case e.Coli and in 1 case mrsa was found.Patient with deep infection needing revision (ae only ¿ expedium system) - in 1 unknown patient with staphylococcus aureus infection, a 2nd revision with debridement, jetlavage, surgical site drainage and antibiotics for 4 months was done.Superficial infection (ae only ¿ expedium system) - unknown patients with open mono stabilizations, bi stabilizations, poly-segmental stabilizations and open stabilization (2006-2010); superficial infection was evaluated.In superficial infections after revision parenteral antibiotics over 3 days, then oral antibiotics depending on the antibiogramm were given.In superficial infections in 3 cases s.Aureus, in 1 case e.Coli and in 2 cases mrse was found.Device malfunction (malfunction only ¿ expedium screws) ¿ screw loosening - in unknown patients with open stabilizations; screw loosening was observed.
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