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 torque and locking mechanism of the mayfield skull clamp (a1059) was unstable.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).Device history record - the dhr documentation showed no abnormalities related to the reported failure.Mayfield modified skull clamp (a1059) was returned for evaluation.The reported complaint was confirmed via inspection of the item.Unit received with the lock having movement and requiring replacement of worn internal parts.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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