The involved plate, within its double-pouch pack, was received at the company and inspected.Based on the examination, the implant was found to be in order, with smooth distal tip (no sharp edges).The distal end of the plate seemed to slightly penetrate the internal pouch sealing.Examination of the production records of the involved plate and its packaging did not reveal deviation from specification.Importantly, the sealing machine used to seal the pouches is validated in the beginning of each working day by performing seal strength test and seal integrity test.Additionally, each pouch is visually examined for sealing integrity following the sealing process.Specifically, the records indicate that the tests conducted at the day the involved product was packed met the tests acceptance criteria.Note: due to restrictions related to the coronavirus situation, the submission of this report was delayed.
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