(b)(4).Concomitant medical products: 113630, comprehensive humeral stem¿mini, 649580; 113042, versa-dial humeral head, 641150; 113954, modular hybrid glenoid base, 255580; pt-113950,modular hybrid glenoid post¿regenerex, 728040.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: 0001825034-2018-07630; 0001825034-2018-07633; 0001825034-2018-07634; 0001825034-2018-07635.Not returned to manufacturer.
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It was reported that the patient had an initial comprehensive total shoulder procedure.Subsequently, one day following the primary procedure, the patient experienced near syncope/dizziness due to an episode of bradycardia.No additional patient consequences were reported.
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