On (b)(6) 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.As the description states an erythema "at superior incision site", we may suppose that the event is due to the allergy to the suture component and not to the titanium.Patient condition may be a cause of the event, considering the sensitivity reported in the medical history.
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