Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.Dimensional examination of the product indicated it was manufactured according to specifications.It may be that excessive torque was used during tightening of the screw.The ifu document for the system instructs the user to avoid the application of high torque during screw tightening, as excessive torque may damage the bone or implants.This report is submitted following an fda inspection at the manufacturer facility.
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