Model Number 00884450379851 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges during a vertebral augmentation procedure, the tip of the augmentation system detached within the patients vertebral body and was not removed.The detached tip was cemented in place and the procedure completed without any additional consequences to the patient.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
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Search Alerts/Recalls
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