D2:type of the device: common device name: avenue l lateral lumbar cage, avenue t tlif cage system, roi-a alif cage system, roi-t implant system additional info in a5, d4 (udi number), e1 (middle name, address ¿ line 1, address ¿ line 2, city), g5 (pma/510k) and h6 (patient code, device code, method code, results code).The product was not returned, so a full evaluation could not be performed.However, with the photographs provided, the complaint is confirmed for the reported failure mode of sterile packaging issue.Per the information available in the complaint file and hhed-2018-00939, it is believed that at some point, this package was opened, then returned to the zimmer biomet distribution site where the shrink wrap was replaced without confirming the contents in the box remained in a sterile condition.However, this cannot be explicitly confirmed, so the cause cannot be determined.The device was likely conforming to specifications when it initially left zimmer biomet's control.No actions are recommended per (b)(4).
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