As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.Based on the data we received, the root cause of the observed dislodgement cannot be determined.The quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Should additional information or the device itself become available for analysis, the investigation will be updated.
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