Catalog Number OS-MON-1001 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Unspecified Infection (1930)
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Event Date 06/04/2022 |
Event Type
Injury
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Event Description
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Abyrx has received preliminary information concerning possible adverse event from sales agent.Additional information concerning the event is being collected.
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Manufacturer Narrative
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Abyrx has received preliminary information concerning possible adverse tissue response from a physician.Initial dos (b)(6) 2022 for mtp fusion utilizing montage in conjunction with two types of third-party collagen-based products.It is unclear if the products were used in accordance with the instructions for use.Abyrx performed a review of device history records for this lot, and no irregularities or nonconformities were noted, including all aspects of sterilization.No additional complaints have been received for this lot.Abyrx will revise the complaint file if any additional information is received.
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Event Description
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Abyrx has received preliminary information concerning possible adverse event from sales agent.Additional information concerning the event is being collected.
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Manufacturer Narrative
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Abyrx has received preliminary information concerning possible adverse tissue response from a physician.Initial dos 2022/04/08 for mtp fusion utilizing montage in conjunction with two types of third-party collagen-based products.It is unclear if the products were used in accordance with the instructions for use.Abyrx performed a review of device history records for this lot, and no irregularities or nonconformities were noted, including all aspects of sterilization.No additional complaints have been received for this lot.Abyrx will revise the complaint file if any additional information is received.
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Search Alerts/Recalls
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