Catalog Number A1114 |
Device Problem
Physical Resistance/Sticking (4012)
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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 received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number 3004608878-2020-00358.
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Event Description
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This is 1 of 2 reports.A customer reported that the two pin side lock or unlock mechanism of the a1114 mayfield infinity skull clamp is sticking.There was no known patient involvement or delay in surgery.
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Event Description
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N/a.
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Manufacturer Narrative
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(b)(4).The device was returned for evaluation.The device history record (dhr) showed no abnormalities related to the reported failure.The returned unit did not meet all specific functional test.The evaluation showed that the lock has rotational and lateral movement also is sticking and a residue buildup was present.Unit needed new components added to replace worn internal parts.The reported complaint was confirmed from the evaluation.The observed condition was likely caused by wear and tear of the device.The definite root cause could not be reliably determined.
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Search Alerts/Recalls
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