One of the most unique aspects of medical device #biocompatibility is just how quickly your work can have a direct impact on patients. The recent issue with the NuVasive MAGEC system components highlights this very well. They issued a recall due to a mechanical failure of some of their products in February 2020. At some point NuVasive performed a #biocompatibility evaluation of that mechanical failure which raised a potential issue. NuVasive issued an updated Field Safety Notice in December 2020 raising the potential #biocompatibility concerns associated with that mechanical failure. The FDA began receiving reports describing local tissue reactions potentially related to the #bicompatibility issues by early 2021. A mere few months between a #biocompatibilty evaluation and an unfortunate clinical result. This is why #biocompatibility is so important!
Additionally, kudos to NuVasive for acting quickly and heading the recommendations of their #toxicologist and #biocompatibilitySME in issuing the updated notice!
#fda#medicaldevices#biocompatibility#toxicology#JLTox