Catalog Number A3059 |
Device Problems
Mechanical Problem (1384); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device was not yet received by the manufacturer for evaluation.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 an a3059 mayfield composite series skull clamp did not lock or unlock smoothly and made a crunching sound.The incident date was unknown.Patient contact, injury, and surgery delay were unknown.Additional information has been requested.
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Manufacturer Narrative
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The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.The device history record review with no abnormalities related to the reported failure.The reported complaint unconfirmed.Root cause analysis cannot be completed at the moment.Device identifier number: (b)(4).
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Event Description
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N/a.
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Search Alerts/Recalls
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