C62968Level 5

Material Integrity Problem

**Semantic type:** Event

**Definition:** Problem associated with any deviations from the documented specifications of the device that relate to the limited durability of all material used to construct the device.

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C133505Device Explosion

C133509Material Split, Cut or Torn

C217073Failure to Degrade

C62832Torn Material

C62846Scratched Material

C62895Material Opacification

C62963Medical Device Material Split

C62964Material Separation

C62967Material Perforation

C62970Degradation

C62971Material Crack

C62972Burst Container or Vessel

C62973Material Break

C63222Material Disintegration

C63224Discolored Material

C63248Material Deformation

C63287Deformation due to Compressive Stress

C72891Material Protrusion

C72894Material Distortion Medical Device Problem

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