Allegedly,the patient (assuming we are talking about a size 2 set of implants) was small framed female.Sales rep is told that exposure was extremely difficult and dr struggled thru the entire case.The cement technique was poor and there was a considerable amount of liquid and fluids present in the wound during application of the cement.The case was a bilateral surgery.He believes both devices required revision in a short period of time following the primary case.It is not confirmed that the devices have been already revised.No part numbers or lot numbers for the devices have been received however, it is indicated that the set of nitrx implants are size number 2.The event regarding the devices implanted on patient's right side are captured under microport orthopedics group number:(b)(4).
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