While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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(b)(6) 2024: returned product 1 palodent v3 universal ring (green, v5 version) overmodling date codes ¿j¿ for october and ¿n¿ for 2022.This ring observed to have the overmolding tynes on one side broken and also noticed not symmetrical to the other side (images attached) and does not meet specification as per 0290-ip-7.5-60-58.There is no batch information provided in this case, therefore no dhr or retain evaluation can be conducted.Nc-2024-606 issued for this non-conformance.(nwv) failure mode: broken product root cause: manufacturing error conclusion code: product failure - manufacturing.
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