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Model Number MN10350-50A |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2022 |
Event Type
Injury
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Event Description
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It was reported that during a drg trial procedure on (b)(6) 2022, part of the sheath had sheared off and remains implanted in the patient.Post-operatively, the patient had no issues and therapy was established.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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