FDA Focused on Biocompatibility Issues of Medical Devices

The Food and Drug Administration warned the healthcare providers on Thursday, July 08, regarding potential Biocompatibility concerns associated with the Precise devices provided by NuVasive. Precise devices are medical implants targeted for a population aging 18 years and the older age group. These devices are used extension or lengthening limb along with procedures for shortening or compressing limb or transportation of segments of long bones.Precise devices include adjustable rods fitted inside a patient’s body, functionally driven by an internal magnetic mechanism.

According to a recently released FDA notice, several reports state the pain and involuntary changes in the surrounding bones and soft tissues in patients who have received an implant of stainless steel-based Precise devices. The side effects are anticipated to result from corrosion, wear, and the incorporation of previously unanticipated exposure of certain elements that are now undergoing Biocompatibility testing.

NuVasive released a statement on April 05 informing healthcare providers of Precise devices currently conducted testing procedures. The Food and Drug Administration also speculated that it is still unsure if the cause of adverse effects is generating from stainless-steel material or has any associations with the design features and materials commonly used in all Precise devices.

NuVasive is currently conducting Biocompatibility tests on the materials commonly used for all Precise devices against the updated standards. The company’s stainless steel-based Precise devices comprise Precise Bone Transport, Precise Plate, and Precise Stryde.