(b)(4).Concomitant medical devices: biomet microfixation sternalock blu system plate, 12 hole jl-plate, catalog #: sp-3215, lot #: ni; biomet microfixation sternalock blu system sternalock 6 hole hex plate; catalog #: sp-2890, lot #: ni; biomet microfixation sternalock blu system screw, cancellous cross-drive locking 2.4 x 14 mm, catalog #: 73-2414, lot #: ni; biomet microfixation sternalock blu system screw, cancellous cross-drive locking 2.4 x 16 mm, catalog #: 73-2416, lot #: ni.Concomitant medical products: therapy date: (b)(6) 2018.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: 0001032347-2018-00897 through 0001032347-2018-00901.
|
This follow-up report is being submitted to relay additional information.The reported event is considered confirmed as a revision was reported.The product was not returned for investigation and no photos were provided.For these reasons, the implants cannot be visually evaluated or functionally tested.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to patient condition.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|