(b)(4).Concomitant products: 47482801602, 2.7mm univ locking scrs st, 63185762; 47482801602, 2.7mm univ locking scrs st, 63185762; 47482801602, 2.7mm univ locking scrs st, 63185762; 47235901438, periarticular locking scrs st, 63138409; 47482801802, 2.7mm univ locking screws ster, 63115789; 47235701708, periarticular lkng plt fib st, unknown; 47484003501, zps screws sterile, 63337311.(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 - 02750, 0001822565 - 2018 - 02751, 0001822565 - 2018 - 02752, 0001822565 - 2018 - 02753, 0001822565 - 2018 - 02754, 0001822565 - 2018 - 02749, 0001822565 - 2018 - 02756.
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