On June 8, 2020, the North American Spine Society (NASS) reported on two spinal device warnings issued by DePuy Synthes and NuVasive, Inc.
Urgent Spine Safety Warnings From DePuy Synthes and NuVasive
2 min read Premium comments
#nuvasiveSecondary#depuysynthes#devicewarnings
DePuy Synthes Polyaxial 3D Head Rings
The first was an Urgent Field Safety Notice initiated by Synthes GmbH on November 11, 2019 for the removal of USS II Polyaxial 3D Heads.
The reason for the removal came after 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.”
The Notice stated that potential “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.”
The company issued instructions to quarantine the product and contact the local DePuy Synthes sales organization.
You can read the Notice here.
NuVasive Model X Rods
The second report was an Urgent Field Safety Notice initiated by NuVasive, Inc., on February 13, 2020 regarding the company’s MAGEC®System Model X rods.
The Notice stated that “post-implantation separation of an actuator end cap component has been observed,” and “post-market surveillance data have shown this actuator end cap separation to have occurred in approximately 0.5% of this device.” The issue has only been observed in Model X rods, so prior version rods of the MAGEC®System are not affected by the [Notice].
The company said separation of the end cap “may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration.”
Surgeons are encouraged to perform routine clinical follow-up and discuss potential clinical implications and risks with patients who received affected rods. At this point, the company is not recommending prophylactic revision based solely on the separation of an end cap. “However, if an end cap separation is detected, removal of the device may be indicated.”
NuVasive is also instructing surgeons to quarantine any devices on hand and meet with a company salesperson.
You can read the NuVasive Notice here.
Both safety notices are considered a moderate-impact “Warning” by NASS.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.