DEPUY ORTHOPAEDICS, INC. 1818910 SLF TAPPING ROOF PILE SCRW30MM; BONE SCREWS AND PINS : SCREWS
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Catalog Number 101140030 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis (2100)
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Event Date 05/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Clinical adverse event received for dvts bilaterally : vascular - dvt.Event is serious and is considered moderate.Event is definitely not related to device and possibly related to procedure.Doi: (b)(6) 2019, dor: (b)(6) 2019 (pelvic fracture: cup, liner, and head revised), doe: (b)(6) 2019, (right hip).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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