(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2018 - 11401, 0001825034 - 2018 - 11402, 0001825034 - 2018 - 11403, 0001825034 - 2018 - 11404.(b)(4).Concomitant medical products: 115740 compr nano hmrl pps 40mm lot 820550, 118001 versa-dial/comp ti std taper lot 260450, 113042 versa-dial 46x18x53 hum head lot 060280, 113954 md hybrid glenoid base 4mm lot 268280, pt-113950 pt hybrid glen post regenerex lot 742260.Foreign- the event occurred in (b)(6).As the devices remain implanted; they will not be returned for evaluation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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