Catalog Number ARC25SB/A |
Device Problems
Material Rupture (1546); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/07/2021 |
Event Type
malfunction
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Event Description
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The account alleges that during a vertebral augmentation, the balloon ruptured while inflating within the spine.Part of the balloon was left behind as foreign body material as the physician was not able to retrieve.The physician states that the foreign body will not migrate and that it is acceptable to leave within the patient.
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Manufacturer Narrative
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The suspect device is 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 that during a vertebral augmentation, the balloon ruptured while inflating within the spine.Part of the balloon was left behind as foreign body material as the physician was not able to retrieve.The physician states that the foreign body will not migrate and that it is acceptable to leave within the patient.
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use and excessive force during use.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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Manufacturer Narrative
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An incomplete medical device was returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.
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Search Alerts/Recalls
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