Catalog Number A2000 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported that the a2000 mayfield 2000 skull clamp was sticking and locking.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
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Manufacturer Narrative
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Mayfield skull clamp (a2000) was returned for evlauation.The reported complaint was confirmed via inspection of the unit.The hex bushing was worn and the lock had movement after being locked down.Unit is beyond integra¿s 7 years recommended life cycle (manufactured in 1996).No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Event Description
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N/a.
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Search Alerts/Recalls
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