Cmp-(b)(4).Four screws were implanted, and two screws were revised.The product identifications were reported in conjunction with this event.It is unknown after follow-up attempts which device(s) were revised and which remained implanted.Revision date was (b)(6) 2011.The information for the additional screws is as follows: item name: 3.0mm ti-screwanchor1blue sutu, catalog number: 902554, lot number: 148700, expiration date: sep 30, 2013, manufacture date: sep 24, 2003.Item name: 3.0mm ti-screwanchor1blue sutu, catalog number: 902554, lot number: 153230, expiration date: apr 30, 2013, manufacture date: apr 10, 2003.Item name: 5.0mm ti-screwanchor dbl2ssutu, catalog number: 902556, lot number: 171200, expiration date: oct 31, 2013, manufacture date: oct 30, 2003.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001825034-2018-01797.Product location unknown.
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