This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: breakage event description: it was reported that the product was implanted on (b)(6) 2018 and revised on (b)(6) 2018 due to ncb plate fracture.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Conclusion: it was reported that the product was implanted on (b)(6) 2018 and revised on (b)(6) 2018 due to ncb plate fracture.No product was returned to zimmer biomet for in-depth analysis.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant were received; therefore the condition of the component is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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