It was reported to the manufacturer on (b)(6) 2023 that the product was implanted in the lateral gutters in the patient on a t8-ilium posterior fusion on (b)(6) 2022.On (b)(6) 2022, the patient presented with a severe infection in the posterior lateral gutters.The surgeon remvoed all the product in the posterior lateral gutters and washed out the area.The patient was brought back for wash out two more times, on (b)(6) 2022 and (b)(6) 2022.All the screws, rods, and set screws implanted along with the product on (b)(6) 2022 remained in the patient.
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