DIRECT injuries to the spinal cord in peace time are encountered relatively rarely and they account for only a small proportion of all spinal cord injuries. They are most frequently caused by firearms or stab wounds. Because no report of a case like that presented below was found by us in the available literature it was thought worth while to describe it here in detail.

The Medical Devices Act (Medizinproduktegesetz = MPG) took effect in Germany on 01. 01. 1995, and replaced (with the exception of diagnostic laboratory devices) the previously binding MedGV with a transition period ending on 13. 06. 1998. The new German act is the implementation of the EC directive on active implantable medical devices (90/385/EWG) and the directive on medical devices (93/42/EWG). The EC directive 93/42/EWG on medical devices permits the manufacturer of a medical device to chose the conformity assessment procedure. All medical devices are subject to conformity assessment procedures, and are awarded the EC mark through Appendix II, III, VII or VIII. All these appendices contain information about the need for carrying out assessment and the obligation to provide a written description of the risk analysis for a medical device. Risk analysis is a common method that verifiably ensures that the basic requirements of EC Directive 93/42/EWG on medical devices are met by the product. It is obvious that risk analysis is of central importance to the legal measures for ensuring appropriate device safety. The present paper presents and assesses various methods of risk analysis.

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