On 03aug2020 the sales manager reported a plate fracture explant in (b)(6) with (b)(4).On 05aug2020 the quality analyst at (b)(4) (osteomed distributor) notifies: "patient (b)(6), victim of trauma to the face by a large animal, underwent a surgical procedure on (b)(6) 2021, where temporary stabilization of the mandibular fracture and sutures of the wounds on the face were performed.On (b)(6) 2021, the patient underwent a surgical procedure to treat a complex mandibular fracture on the right side and middle third of the face.At the time, 01 (one) straight plate bsso 04 holes, 01 (one) straight plate bsso 06 holes and 01 (one) trapezoidal plate 05 holes of the 2.0 locked angled system of the osteomed brand were used for fixation of the mandibular fracture of tlhe middle 1/3 of the face.It turns out that, after routine examinations, an image compatible with a 06 hole plate fracture was found in the basilar region of the mandible body.New surgical intervention was performed today (b)(6) 2021, where the two straight angled bsso boards blocked "fron" the 2.0 system were removed and replaced by 01 (one) board 2.4 angled blocked with 6 holes.".
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The device was not returned for evaluation despite follow up attempts; however, photos were provided that showed the fractured plate.A two year review of capa, ncr, and complaints revealed no capas, ncrs, or complaints of broken bsso plates for this device system.Labeling was reviewed and indicated the instructions for use provides various warnings related to fractured/broken plates.Additionally, risk documentation was reviewed and adequately addresses this failure mode.The device history record was reviewed to ensure each manufacturing and inspection operation was performed.The review revealed no anomalies.
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