No product returned for evaluation as it remains in-situ, nor allegation of product malfunction.No revision procedure is planned at this time.Label review: ".Warnings, cautions and precautions: caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials." ".Contraindications: contraindications include but are not limited to: infection, local to the operative site, signs of local inflammation, patients with known sensitivity to the materials implanted.".
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