Model Number 101-9812 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model # 140-9800, serial # (b)(4), description: vertiflex instrument platform.
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Event Description
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It was reported that the procedure was aborted due to the physician having difficulty advancing the spacer through the cannula.Upon inspection of the spacer, it had been slightly bent.The patient was reportedly doing well following the procedure.
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Manufacturer Narrative
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Analysis of the 12mm spacer lot number 700078 was unable to confirm the reported complaint.The spacer was subjected to visual and functional examination.No defects could be confirmed as the spacer was completely intact and functioned acceptably.Analysis of the dilator of the cannula assembly lot number 193834 was unable to confirm the reported complaint.The device was subjected to visual and functional examination.No defects could be confirmed as the instrument was completely intact and functioned acceptably.
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Event Description
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It was reported that the procedure was aborted due to the physician having difficulty advancing the spacer through the cannula.Upon inspection of the spacer, it had been slightly bent.The patient was reportedly doing well following the procedure.
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Search Alerts/Recalls
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