(b)(4).Concomitant medical products: 47234801635, periarticular screws sterile, 63486170, 47234801635, periarticular screws sterile, 63085306, 47482801602, 2.7mm univ locking scrs st, 63416587, 47234801635, periarticular screws sterile, 63486170, 47482801802, 2.7mm univ locking screws, 63500426, 47482801802, 2.7mm univ locking screws, 63500426, 47482802002, 2.7mm univ locking screws, 62602704, 47234801435, periarticular screws, 63486167, 47235701706, periarticular lkng plt fib st, 63202116.Report source, foreign - the event occurred in the (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 03168, 0001822565 - 2018 - 03169, 0001822565 - 2018 - 03170, 0001822565 - 2018 - 03171, 0001822565 - 2018 - 03172, 0001822565 - 2018 - 03173, 0001822565 - 2018 - 03174, 0001822565 - 2018 - 03167, 0001822565 - 2018 - 02639.
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It was reported that the patient's trauma plate was revised due to redness, soft tissue irritation, pain, infection, and swelling.Upon explantation, it was noted that there was corrosion and discoloration on the plate.Attempts have been made and additional information on the reported event is unavailable.
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It was reported that the patient's trauma plate was revised due to redness, soft tissue irritation, pain, infection, and swelling.Upon explantation, it was noted that there was corrosion and discoloration on the plate.Attempts have been made and additional information on the reported event is unavailable.
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