The product liability attorneys at Cutter Law P.C. are investigating claims involving Lava Ultimate Crown products, dental procedure devices manufactured by 3M ESPE Dental.
On June 15, 2015, Minnesota-based manufacturer 3M recalled all lots and category numbers for the Lava Ultimate CAD/CAM Restorative and the Lava Ultimate Implant Crown Restorative after approximately 10 percent of dental accounts had reported that the crowns debonded at a rate higher than the industry standard. According to the company's "Field Safety Corrective Action" notice, "the reported debond rates varied greatly and often significantly exceeded the 2-4 percent rates generally reported in clinical literature."
Approved by the U.S. Food and Drug Administration (FDA) in January 2011, the Lava Ultimate Restorative is used for inlays, onlays, veneers and full crown restorations, including implant supported crowns, permanent three unit bridges in the anterior region and permanent three unit bridges in the premolar region up to the second premolar as the terminal abutment.
The products continue to be used for inlays, onlays (with an internal retentive design element) and veneer restoratives, per new instructions for use (IFU) issued by 3M.
Lava Ultimate Crown Side Effects
In July 2015, the FDA announced a Class II classification for the recalled devices. This categorization cites that the device "may cause temporary or medically reversible adverse health consequences."
Reported injuries associated with the failure of the Lava Ultimate devices include:
- Persistent sensitivity
- Need to undergo an endodontic procedure (i.e., root canal)
- Tooth loss or extraction
Contact A Product Liability Attorney
If you or a loved one has undergone a dental procedure in which your crown debonded and caused injury, you may be entitled to compensation for your pain and suffering. Contact the injury attorneys at Cutter Law P.C. to set up a free case evaluation.
Because we are a contingency-based firm, there is never an upfront cost to you. We front all costs to prosecute your claim and get paid only if we win a monetary recovery. Give us a call toll free at 888-285-3333 or fill out the contact form below.