Method of evaluation: actual device not evaluated; manufacturing review.Review of information as reported, review of the device history records and complaint history records associated with lot sp100401.Results of evaluation: no failure detected.Review of lot processing history and complaint history records for lot sp100401 was unremarkable.There were no processing deviations or nonconformance related to the nature of this complaint and the lot met qc criteria for release, including mechanical testing results.As of 03/24/2017, one other complaint ((b)(4)) was reported to lifecell against lot sp100401.As per the surgeon, the strattice did not cause or contribute to the event.The event is unrelated to strattice and not reportable to the fda.As of 03/24/2017, of the (b)(4) devices released to finished goods for lot sp100401, (b)(4) devices were distributed.Evaluation conclusion: device not returned; device failure related to patient condition.The event is unlikely related to strattice and likely due to the patient's post operative occupational activities which involves lifting heavy loads.Based on our internal review of the device processing history, the lot met qc criteria for product release.No deviations were encountered in association with the event.No other similar complaints were reported to lifecell against the lot.Device not returned for evaluation.
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