Device is a veterinary product.No patient information will be reported.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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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This report is for a veterinary case.There was no human patient involvement.It is reported patient underwent a right tibial plateau leveling osteotomy (tplo) procedure on (b)(6) 2017.Initial surgery went well with no reported issues.Patient was returned to emergency hospital with fever of 105 degrees and loss of appetite on (b)(6) 2017.Bloodwork and x-rays taken that day revealed the bone was healed but an infection in the bone at the implant site was noted.Antibiotics and fluids reduced the fever, only to have the fever recur again on (b)(6) 2017.Patient was returned to surgery on (b)(6) 2017 where surgeon removed all hardware intact.A culture was done on (b)(6) 2017 to determine the correct course of antibiotic needed.Surgeon also noted the entire leg is infected, including the tibia and femur.Patient was discharged from the facility on (b)(6) 2017 with a prescription of tramadol and an appetite stimulant as the patient would not eat on their own.On (b)(6) the patient was re-admitted to the hospital with a fever, suspected pancreatitis, and swollen lymph nodes.Due to lack of appetite, patient was placed on a feeding tube for forty-eight hours.A biopsy has been scheduled to address swollen lymph nodes.Patient is canine.This report is for one (1) 2.0mm self-tapping cortex screw.This is report 3 of 6 for (b)(4).
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