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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The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number 3004608878-2020-00251.
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Event Description
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This is 2 of 2 reports.A customer reported that the locking bolt of the a1114 mayfield infinity skull clamp was loose.There was no known patient injury or delay in surgery.
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Manufacturer Narrative
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(b)(4).The device was returned for evaluation.The lock had rotational and lateral movement and a residue buildup was present.The unit also needed new components added to replace worn internal parts.The dhr documentation for lot number 104 was reviewed and showed no abnormalities related to the reported failure.The reported complaint was confirmed.The lock was loose and would need maintenance.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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