The lot numbers involved in the alleged incidents were not returned; therefore, a physical evaluation was performed on a retained sample for each of the lots, yielding results within specifications.In addition, no similar complaints were received with regard to any of these lots.
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Although the doctor identified fourteen (14) different lots associated with not curing, the doctor could not verify which lot was used on the patient.The lots involved in the alleged incident include 4586772, 4594223, 4862345, 4916637, 4982755, 4996028, 4950206, 4960403, 4201571, 4568733, 4211007, 4397297, 3694407, and 4665691.Patient specifics with regard to gender, age, and weight were not provided.The cured and uncured composite was drilled out and replaced using a new herculite ultra tip during the same office visit.To date, the patient is doing fine.The product involved in the alleged incident has not been returned.An evaluation of retained samples is anticipated, but has not yet begun.
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