Catalog Number A1059 |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
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Event Description
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A customer reported that they just received a new a1059 mayfield modified skull clamp and that it appeared to have crack in it.This is an out of box failure.
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Event Description
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N/a.
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Manufacturer Narrative
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The device was not released for evaluation therefore the failure analysis to identify root cause to the end user's experience could not be determined.A device history record review could not be performed as lot or serial number of the device was not provided.The complaint was unconfirmed.
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Search Alerts/Recalls
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