Visual, dimensional, functional inspection, and material analysis could not be performed as the device remains implanted.Complaint history records were reviewed for the lot number provided and no similar events were identified.Manufacturing history records were reviewed for the lot number provided and no relevant manufacturing issues were identified.From the surgical technique guide: ¿foreign body sensitivity.Where material sensitivity is suspected, appropriate tests must be made prior to material selection or implantation.¿ the material of the blocker is titanium alloy: ti6al4v according to iso 5832-3 and astm f-136 which is composed of titanium, aluminum and vanadium.The above material specifications do not specify "nickel, chromium or cobalt" as a component.Allergic reactions to implants are most common with nickel, chromium, cobalt.Based on the information provided, it cannot be confirmed that described patient¿s symptoms are implant related, as the listed implants do not contain nickel, chromium, nor cobalt.The results of the patient¿s allergy testing was not provided.No revision surgery planned.
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