Model Number MAYFIELD HEAD HOLDER ADAPTOR |
Device Problem
Bent (1059)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The mayfield head holder adapter from device br16025 has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.
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Event Description
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It was reported that after being used for the last surgery the mayfield head holder adaptor was in perfect condition, and after was found damaged within the storage area.Site claims they do not know what happened, but suspect that it was damaged in the storage area or in the hallway during transit.
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Manufacturer Narrative
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It was reported that the pin of a mayfield head holder adaptor was found bent.According to visual inspection, the damage could not have been caused by tightening of the part with excessive force.According to the medtech representative, the part was correct during the previous surgery.According to the hospital, the part could have been damaged during storage or transit.The most probable root cause is that the part was dropped down during storage or transit within the hospital.
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Search Alerts/Recalls
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