美国食品药品监督管理局（FDA）最新披露，截至12月4日，医疗设备制造商史赛克（Stryker）报告其患者定制颞下颌关节（TMJ）植入物相关问题导致1例严重伤害事件，目前未出现死亡病例。
该监管机构指出，此次事件涉及特定型号的患者定制植入物，但未披露具体产品批次及伤害事件细节。颞下颌关节植入物主要用于治疗下颌关节严重损伤或退行性疾病患者，而定制化植入物需根据患者个体解剖结构进行专门设计。
FDA强调正在持续监测相关情况，并要求医疗机构按要求上报与该植入物相关的不良事件。史赛克公司此前已就潜在风险发布过产品通知，建议医护人员对出现异常症状的患者进行密切随访。
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