This mdr is being reported as a multiple event type for serious injury.The corresponding author has not provided additional clinical information.The device was not returned for evaluation and the lot numbers remain unknown; therefore, internal investigation into the event could not be performed.Based on the reported information, a relationship between the event and strattice cannot be determined.If additional information is reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.
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Literature of retrospective analysis in (b)(6) comparing the use of strattice with seragyn br and tiloop bra meshes for implant-based subpectoral breast reconstruction.Strattice was use in 52 of 362 reconstructions.The authors list the details of postoperative complications in various tables of the public literature.¿overall distribution of individual complications¿.Overall, major complications occurred in 28.8% and minor complications in 26.9% when adm was used.When using the prsm, major complications occurred in 14.7% and minor complications in 15.7%, and with the nrsm, major complications occurred in 15.4% and minor complications in 11.7%.Thus, the rates of major and minor complications with the use of adm are approximately twice as high as with the sms, which are similar to each other.
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