FDA MAUDE Reports
When we checked the FDA’s MAUDE (Manufacturer and User Facility Device Experience) reports, we found 43 from April 27, 2016 to December 19, 2018 regarding 3D-printed lumbar cages (all manufacturers, not just Stryker). As this article was being written, there were no new MAUDE reports of breakages since the November 28, 2018 recall.
As Stryker reported in the recall notice, 28,461 units of the Tritanium PL have been put in commerce (which means sent, not necessarily yet implanted) since the device was cleared for the market on November 19, 2015 under 510(k). The 43 MDRs (Medical Device Reporting Program) reports since then constitute a notably small percentage of the total in commercial circulation.
Critics say, however, that because MAUDE reports are voluntary, they likely represent only 5% to 20% of all incidents.
The content of some reports indicates that some surgeons who experienced the breakages think the problem is more than surgical insertion technique. A February 19, 2018 MAUDE report said in part:
“…Using standard surgical technique, I inserted the inter body device into the prepared l2-l3 disc space. The initial 50% of insertion was by manual pushing, and the final 50% of insertion by gentle tapping on the back end of the inserter device with a mallet. Once in place, a fluoroscopic image was taken, that demonstrated an abnormal slight obliquity to the device. Upon inspection, I discovered that the proximal (i.e., portion nearest the junction with the inserter) one third of the implant had separated (fractured) from the rest of the implant, and other parts of the implant had simply crumbled… Upon inquiring about this failure with stryker reps later that day, I was informed that stryker is aware of over 20 cases where a tritanium implant has fractured into pieces during surgical implantation. Obviously, I find this extremely alarming as a tritanium inter body implant should not break into pieces during insertion, and it furthermore makes me very concerned whether such tritanium devices will remain functional and in one pieces when subjected to constant loading cycles in an upright and ambulating pt.”
A report on a May 2, 2018 breakage:
“It was reported that upon insertion of the cage at the l5-s1 level broke in two pieces as the cage was advancing into the disc space. The surgeon was following correct insertion guidelines and was not handling it aggressively or using excessive force. The surgeon was able to distract the disc space enough to retrieve the broken piece….”
Not for Overweight or Obese Patients or Those Who Vigorously Exercise
Also, Stryker cautions against implanting the Tritanium PL in patients who are obese or who exercise frequently or vigorously:
“Obesity. An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation or to failure of the device itself.”
“Patients involved in an occupation or activity that applies excessive loading upon the implant (e.g. substantial walking, running, lifting or muscle strain) may be at risk for failure of the fusion and/or the device.”
These contraindications and cautions about who should not receive the device are available online if you look in the right document. They’re not on the Tritanium PL microsite or in a product brochure or a technical summary, but they are in the online “Surgical Technique” document, on page 26 of the original and page 29 of the latest update.
One of the surgeons we interviewed told OTW, “More than half the U.S. population is obese and most of our patients have surgery to return to physical activities such as walking or running.” The other also questioned whom the device is for, if overweight and obese people and those who exercise significantly are contraindicated.
