Catalog Number 28-L2-15-120U |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2023-00036, device 2 is being reported under mdr-2247858-2023-00037, and device 3 is being reported under mdr-2247858-2023-00038.
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Event Description
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Core lab identified a fracture from the subject's 12-month imaging from (b)(6) 2022.The site has been informed.Patient outcome - "pending patient outcome from the site as they were not aware of the fracture.".
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Manufacturer Narrative
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This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2023-00036, device 2 is being reported under mdr-2247858-2023-00037, and device 3 is being reported under mdr-2247858-2023-00038.
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Event Description
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Core lab identified a fracture from the subject's 12-month imaging from (b)(6) 2022.The site has been informed.Patient outcome - "pending patient outcome from the site as they were not aware of the fracture.".
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Search Alerts/Recalls
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