Catalog Number A1114 |
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 locking knob on the mayfield skull clamp (product id a1114) was not working properly.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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Unique device identifier (udi): (b)(4).Mayfield infinity skull clamp (a1114) was returned for evaluation.Complaint confirmed via inspection of the unit.The lock is sticking and unit requires replacement of worn internal parts.The device is beyond integra's 7 years recommended life cycle (manufactured in 2013).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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Search Alerts/Recalls
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