(b)(4).Concomitant medical products: crs humeral tray ¿ cat.No.115340, lot no.561910, crs glenosphere baseplate ¿ cat.No.115330, lot no.514450, crs central screw ¿ cat.No.115383, lot no.552680, fixed locking screw ¿ cat.No.180501, lot no.918900, fixed locking screw ¿ cat.No.180503, lot no.186950, fixed locking screw ¿ cat.No.180502, lot no.988280, fixed locking screw ¿ cat.No.180500, lot no.432960, fixed locking screw ¿ cat.No.180503, lot no.186960, crs humeral bearing ¿ cat.No.Xl-115363, lot no.176400, crs glenosphere ¿ cat.No.115316, lot no.803450, crs stem ¿ cat.No.113628, lot no.098490.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Product location unknown.
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