According to the safety notice out of Germany, Synthes GmbH is initiating a voluntary medical device product removal of USS II Polyaxial 3D Heads. The USS II Polyaxial 3D Head is part of the USS II Polyaxial System which is a posterior pedicle screw fixation system (T1-S2) designed to provide stabilization of the spine in skeletally mature patients.
Reason for the Medical Device Product Removal
A complaint trend was identified for unusual intra-operative sounds associated with use of the subject medical device and cracking of the USS II Polyaxial 3D Head ring.
Potential Patient Impact
Intra-operative or post-operative breakage of the USS II Polyaxial 3D Head rings may result in loosening of the rods which may cause poor spinal mechanics, non-union or malunion, pain, dislocation, and/or loosening.
Serious surgical delay could occur if a cracked USS II Polyaxial 3D Head ring is identified and corrected intraoperatively. Minor surgical delay could occur if audio cues cause surgery to be paused while the source of the noise is investigated, but no crack or breakage is identified.
Synthes GmbH is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons perform routine clinical follow-up and discuss potential clinical implications and risks with symptomatic patients who received the affected implants.