Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Date 02/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 115310 comp rvrs shldr glnsp std 36mm 129260; 010000589 comp rvrs 25mm bsplt ha+adptr 592930 ; 115370 comp rvs tray co 44mm 596600 ; ep-115393 e1 44-36 std hmrl brng 734030 ; 180558 comp nlk scr 3.5hex 4.75x20 st 860890 ; 180560 comp nlk scr 3.5hex 4.75x30 st 018440 ; 115397 comp rvs cntrl 6.5x35mm st/rst 569900.The investigation is in progress.Once the investigation is completed a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 06009; 0001825034 - 2018 - 06014; 0001825034 - 2018 - 06029; 0001825034 - 2018 - 06031.
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Event Description
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It was reported that the patient underwent a reverse total shoulder arthroplasty, and was revised due to unknown reasons approximately five (5) months post-implantation.No additional information is available at this time.
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Manufacturer Narrative
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Upon reassessment of the reported based on additional information.It was determined that the product did not contribute to the reported event.The initial report submitted should be voided.
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Event Description
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Upon reassessment of the reported based on additional information.It was determined that the product did not contribute to the reported event.The initial report submitted should be voided.
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Search Alerts/Recalls
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