Catalog Number A1114 |
Device Problem
Loose or Intermittent Connection (1371)
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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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Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A customer reported that the swivel wheel on the two pin side of the mayfield infinity skull clamp headholder was loose.There was no known patient injury or surgery delay.
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Manufacturer Narrative
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Unique device identifier (udi): (b)(4).Mayfield skull clamp was returned for evaluation.Device history record (dhr): the dhr shows no abnormalities related to the reported failure.Unit received with the lock having rotational and lateral movement and a residue buildup was present.Complaint confirmed via inspection of the unit.The index knob was loose, 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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Search Alerts/Recalls
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