This device was used for treatment, not diagnosis.Patient¿s case id: (b)(6), height- 5¿5¿, bmi- 25.8.(b)(4).The product will not be returned.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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It was reported that originally on (b)(6) 2015 the patient went through an open reduction internal fixation procedure for a right proximal tibia fracture and was implanted with one (1) medial proximal tibia plate, one (1) locking compression (lcp) proximal tibia plate, three (3) cortex screws and nine (9) locking screws.The patient went in for a post-operative follow up visit and it revealed an infection of right proximal tibia.On (b)(6) 2016, a decision was made to remove all hardware and treat the patient with antibiotics; all of the hardware was removed intact.It was reported that the procedure was completed successfully with no surgical delay and the patient's status was stable.This report is 6 of 14 for (b)(4).
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