Product performance data for the last year - Implants - BM86 AIn the absence of exact figures, an estimate may be provided (if not relevant, please leave blank)Unofficially notified investigation baseline dataPartner company:The exact type of devices concerned:Number of devices implanted/used:Number of patients:Feedback date:Number of successful transplantsNumber of implantations where an adverse reaction/complication occurredNumber of implants lost or removedCauses of implant failures and removalsDistribution of side effects by typecan be expressed as number of units or as a percentageThrombosis, embolism:Excessive bleeding:Nerve and vessel damage:Soft tissue damage (swelling, abnormal wound formation):Musculo-skeletal functional impairment:Allergy or hypersensitivity:Lack of bone healing or inadequate bone healing:Significant bone loss around the implant:Other:Number of device-related adverse eventsDevice breakage, cracking:Tool deformation:Usage error related to the application of the device:Other:Average functional satisfaction with the implants after implantation1-not satisfied at all, 5-fully satisfied012345Average aesthetic satisfaction after use of the tool1-dissatisfied, 5-fully satisfied012345Were the assets exposed to extreme stress?yesnoWay of extreme stressIn the case of removal, radiological examinations after implant removal show good bone healingyesnoIn case of removal, deformation, deviation, abnormality of the device identified after removal of the implantcrack, abnormal deformationcorrosionbent screwotherOther deformation, deviation, abnormality, etc.Other comments, ideas, observationsSubmit
