Medical Device Material Integrity Issue

Issue associated with any deviations from device documented performance specifications relating to the limited durability of all material used to construct the device. (Food and Drug Administration)

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Medical Device Material Fragmentation

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

Medical Device Material Degradation

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

Medical Device Material Crack

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

Medical Device Markings Issue

Issue associated with the written, printed or graphic material that is affixed to a medical device or any of its containers or…

Medical Device Maintenance Issue

Issue associated with the servicing of a device.

Medical Device Maintenance Does not Comply to Manufacturers Recommendations

Issue associated with the non-compliance or non-performance to manufacturer specifications relating to device routine maintenance, i.e., periodic inspection, failure detection, repair, and…