MHRA Warns of Issues with DePuy Synthes’ Spinal Fixation System
July 14, 2020
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has warned that components of DePuy Synthes’ spinal fixation system could cause problems for implanted patients.
The regulator said that certain batches of the firm’s USS II Polyaxial 3D Heads, part of its USS II Polyaxial system, may crack during or after surgery and lead to poor spinal mechanics, pain, dislocation, or loosening of the implant.
The company said surgeons should “discuss the potential clinical implications and risks with symptomatic patients who received the affected implants.”