Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker performed a clinical review regarding the reported issue.And, it was concluded that it is likely that lucas caused the lung contusion, but the lucas compressions were not likely to be the cause to the sepsis and necrotizing pulmonary infection.Regarding the comment about safety and efficacy of lucas, especially in obese patients we are not able to comment on.There are + 500 publications with lucas, from randomized controlled trials to case report and this is the first time we hear anything about the safety and efficacy in obese patients.The device was not returned to stryker for evaluation.The cause of the reported issue could not be established.
|