Dental Implant Register Patient Dental Profile 14 October

Dental Implant Register & Patient Dental Profile 14 October 2003 med. Xchange© Private & Confidential 1

Implant Register & Profile: Objectives • Medical incident reports & notification • Consumer protection • Implant & treatment planning • Post Manufacturing Surveillance, PMS • Implant product tracing & tracking • Brand protection 14 October 2003 med. Xchange© Private & Confidential 2

Continuity of implant treatment Treating Dentist Operating Dentist Patient Centric Integrated Electronic Medical Record Dental Implant Treatments 14 October 2003 med. Xchange© Private & Confidential 3

Implant Register & Profile Confidential data exchange point Medical and dental documentation Medically credible trustworthy sources Implant Product Register Data proprietary to manufacturer Patient Implant Profile Link to manufacturer implant data Implant & treatment planning, Post Manufacturing Surveillance, PMS 14 October 2003 med. Xchange© Private & Confidential 4

Product Register - Catalogue • All information updated by manufacturer (Data proprietary to manufacturer) • • 14 October 2003 Reference and serial number Search by characteristics Descriptions, documentation Implant procedures Link to implant planning Product incident reports Product notifications med. Xchange© Private & Confidential 5

Implant Profile 1. Tracks and traces to dentist & patient 2. Links patient profile to manufacturer implant data 3. Linked to patient Dental Card 4. Implant procedure, treatment 5. Treatment and care 6. Post implant incidents and treatments 7. Implant incident reports 8. Post implant tracing and tracking 14 October 2003 med. Xchange© Private & Confidential 6

Integrated Electronic Medical Record • Intuitively understandable by healthcare professionals worldwide • Ergonomically structured • Easy to consult by patient 14 October 2003 med. Xchange© Private & Confidential 7

Implant Report & Analysis 14 October 2003 • Implant activity profile • Implant dental profile • Incident report analysis • Post implant analysis • Implant patient monitoring (Dentist) • Medical & regulatory authority reports med. Xchange© Private & Confidential 8

Post Manufacturing Quality Management Implant tracing & tracking Implant planning Post implant treatment and care Medical incident reporting Implant notices and alerts Post Manufacturing Surveillance, PMS Operating & treating dentist follow-up 14 October 2003 med. Xchange© Private & Confidential 9

Data Protection & Access Management EC Health Card or USB Key “access key” Patient controls access to record Certain data updated by patient Medical data certified by dentist All data traced to source Dentist can restrict access to data Dentist & Patient notified of updates 14 October 2003 med. Xchange© Private & Confidential 10

Manufacturer Benefits • Immediate trace of all implant products • Report of each implant procedure • Better incident reporting • Immediate notifications & alerts • Decrease implant incidents • Increased efficiency and success rate 14 October 2003 med. Xchange© Private & Confidential 11

Operating & treating dentist: Benefits • • 14 October 2003 Identification & authentication of implant products Identification of best implant practices and products Reduction of implant risks Reduction of inappropriate procedures Reduction of procedure complications Reduction of post-implant reactions Decrease implant incidents Timely identification and reaction to incidents med. Xchange© Private & Confidential 12

Patient Benefits • Security of regulated implant product and procedure • Better identification and management of risks • Reduction of implant risks • Security of early warning system integration • Reduction of subsequent medical incidents • Reduction of post-implant reaction 14 October 2003 med. Xchange© Private & Confidential 13

Post-implant patient care: Benefits • Optimization of treatment and care • Reduction of risks • Efficient post implant treatment and care 14 October 2003 med. Xchange© Private & Confidential 14

Why the Dental Implant Register? • Integration of patient in the implant process • Increase quality of post manufacturing surveillance, PMS • Enhance relationship with dental care professionals • Reduce risks of implant incidents • Enhance relationship and confidence of patients 14 October 2003 med. Xchange© Private & Confidential 15