Device Problems
Labelling, Instructions for Use or Training Problem (1318); Product Quality Problem (1506)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
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Event Description
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The customer reported that they are concerned regarding the accuracy of the arc of the g frame.
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Manufacturer Narrative
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Updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The system has been investigated by brainlab who have concluded that there was a lack of lubrication.Initial tests of the system showed that there were problems in movement and locking.After cleaning and lubrication of the system, according to instructions for use maintenance section, it works as intended.The user has been informed by brainlab regarding the importance of lubrication.
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Event Description
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The customer reported that they are concerned regarding the accuracy of the arc of the g frame.
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Search Alerts/Recalls
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