This follow-up mdr is created to document the conclusion of the investigation.The device remains implanted.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no significant trends for lot 5537079.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.
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