Investigation: production process: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Patient removal surgery and x-ray analysis: during the extraction of the system on (b)(6) 2021, the infection was evident on the area of the jazz band and proximal screws.Corrective action: the company decided to open capa (b)(4) to address an in late infection issues on 2019 the capa investigation did not identify a manufacturing problem with implants used in patients that developed a late infection and the late infection rate noted was within the rate reported in the literature.The company did however identify that sites applying vancomycin powder before wound closure have a significantly lower rate of late infection complaints.The company communicated these findings of applying vancomycin powder before wound closure to the surgeons (b)(4) and is continuing to follow the rate of late infection complaints.In the present case, the surgeon used vancomycin antibiotics during the original implantation.Risk assessment: the risk of pain is a known risk that has been assessed and found to be acceptable (dms#(b)(4)).Event of pain addressed in the ifu warnings and precautions section: "metallic implants can loosen, fracture, corrode, migrate, or cause pain" late-onset infection is a known risk that was assessed and recorded by the product risk assessment (b)(4) rev q hazard id 21.5 this complaint does not change the occurrences rate.The rates of late infection in surgeries where vancomycin was used is currently 0.6% which is well within the literature (0.2%-12.5% ,cer 727 rev t).The company is continuing to monitor late infection complaints.
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