(b)(4).Concomitant medical products: catalog #: 47494500411, 4.5 mm l-buttress plate angled left 4 holes 85, lot #: unknown.Catalog #: 47494500412, 4.5 mm l-buttress plate angled right 4 holes 85, lot #: unknown.Catalog #: unknown, unknown screws, lot #: unknown, qty.(b)(4).Report source: france.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02741, 0001822565-2022-02743, 0001822565-2022-02745, 0001822565-2022-02746, 0001822565-2022-02747, 0001822565-2022-02748, 0001822565-2022-02749, 0001822565-2022-02750, 0001822565-2022-02752.
|
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|