Model Number 6003-200-010 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2023 |
Event Type
Injury
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Event Description
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Per the customer, on (b)(6) 2023 while using the navigated jig, a piece came off the cutting block.On (b)(6) 2023 an additional surgery was performed to remove the piece.The additional surgery was completed successfully without a surgical delay; no further medical intervention or adverse consequences were reported.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document the device evaluation.
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Event Description
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Per the customer, on (b)(6) 2023 while using the navigated jig, a piece came off the cutting block.On (b)(6) 2023 an additional surgery was performed to remove the piece.The additional surgery was completed successfully without a surgical delay; no further medical intervention or adverse consequences were reported.
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Search Alerts/Recalls
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