Catalog Number A1059 |
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 rocker arm on the mayfield modified skull clamp (a1059) does not lock.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
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Event Description
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N/a.
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Manufacturer Narrative
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The mayfield skull clamp was returned for evaluation.The reported complaint was confirmed via inspection of the item.Unit received with the lock having rotational and lateral movement and a residue buildup was present.Unit needs new components added to replace worn internal parts.The rocker arm was stiff and the index knob was not holding.This unit is beyond integra¿s 7 years recommended life cycle (manufactured in 2012).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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