Medical Device Material Rupture

Issue associated with the comprising material(s) being penetrated, pierced or punctured, especially with a sharp or pointed object.

Issue associated with an undesired material damage characterized by closely spaced punched or drilled holes.

Issue associated with any deviations from device documented performance specifications relating to the limited durability of all material used to construct the…

Issue associated with small pieces of the device breaking off unexpectedly.

Issue associated with a deleterious change in the chemical structure, physical properties, or appearance in the materials that are used in device…

Issue associated with an undesired separation and/or a visible opening along the length or width in the materials that are used in…