The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.
No strattice devices were returned for evaluation.
Based on the limited information reported, a relationship between the event and strattice could not be determined.
Due to the legal process, if additional information is made available during legal proceedings, the information will be sent to product surveillance for further evaluation.
To date, no additional information has been received.
No further actions are required, a nonconformance was not confirmed.
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