A complainant alleged that a patient had to undergo surgery due to damage caused to the alveolar nerve and to alleviate pain.The surgeon noted that there was a small piece of sealer found beyond apex of #18.It was also stated that allegedly the sealant had leaked out and damaged the alveolar nerve.The initial doctor that put the tubli-seal sealant stated that the procedure was done three years prior and did not use any other material.No lot number was provided, however review of the ifu/dfu was conducted.Such risks were identified on the ifu/dfu.The product is unavailable for return.
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