The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the fixation of sutures and soft tissue with the sonicanchor¿ which was released in (b)(6) 2018 and is associated with the stryker sonic anchor system, within that report, postoperative complications/ adverse events were reported, which occurred between february 2016 and april 2018.Based on the available device and patient information and a review of complaint handling database it was revealed that the events have not been reported by the hospital or by the author of the report, therefore 12 complaints were initiated retrospectively for different adverse events mentioned in the journal.The patient presented with a device related reaction and deep infection, which ultimately required removal of the implant and the nonabsorbable suture.The patient was taken to the operating room for 2 wound debridement procedures and ultimately required a fourth surgery to remove the suture anchor and suture.This product inquiry addresses the first wound debridement.
|