Initial communication received from the patient about this event did not include specific information about the implant (size and lot number).Likewise, no contact information for the implanting surgeon was provided.Product information, the physician's name and contact information, details surrounding the second surgical intervention, and additional details regarding the reported event as described were not made available for investigation.As a result, a review of the quality and manufacturing records for the involved device (implant) lot could not be carried out, nor a patient impact assessment could be performed.At the present time, the event could not be definitely confirmed.Should additional details be provided in the future, an update to this submission will be provided.
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Patient feedback received via third-party patient market survey where the subject reported implant removal and conversion to an unspecified alternate procedure after the implant "shifted" and "fractured" the upper edge of the metatarsal bone.No information about implant date, removal date, procedure performed, physician name and contact information or clinical assessment was made available.
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