(b)(4).Manufacturing site evaluation: according to the available information, there were no negative consequences for patient.Received the upper disc of an ff490t.At the first sight, there are no damages visible.A visual inspection of the disc, especially the spring segments.The disc is not bent or scratched.Only slight wear marks (caused by the application) are visible.The spring segments are in a proper condition (not bent or damaged).The definitive lot is unknown.The possible lots (52397378 / 52436748), been checked and found to be according to specification valid during the time of production.There are no similar cases at hand since the last three years.The root cause for the problem is most probably usage related.A capa is not necessary.
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It was reported by the healthcare professional to the company sales representative "when procedure of closing the skull, upper disk was loosened after the procedure.When the procedure was complete, the lower disk and pin remained.Feedback of the surgeon; free bone flap was relatively big, but fixed with 3 clamps.The surgeon decided to leave the clamp without upper disk.Currently no detailed information about surgery delay of 15 minutes or more.Information is requested.Only the upper disk is available for the investigation.There are two possible batch numbers reported from by the hospital.One is 52397378 and the other is 52436748.According to the hospital, it is possible that 52436748 is the one used.Received contaminated upper disk.
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