Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Materialise N.V.
The wrong tibia guide was included intended for a different patient case.
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
Class I - Dangerous
Custom surgical kits contain a plate different than indicated by the package labeling.
Class I - Dangerous
Custom surgical kits contain a plate different than indicated by the package labeling.
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.