(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
(b)(6).During the surgery with viper 2 system, the patient went into the cardiac arrest, followed by the reanimation that was not successful.The patient was an older female, (b)(6), with bechterew disease.The surgery was almost finished at the time of the event, with all the screws inserted and finished vertebroplasty in 6 vertebral bodies.The 12 viper screws/innies, 2 titanium rods, 3 confidence cements.Or doctor provided a medical rationale that indicates the use of the product is in no way related to the reported event: the patient had preexisting medical conditions that could potentially result in the outcome.
|