Medical device maker Medtronic Inc. said it did not encourage the unapproved use of its spinal implant, which a new lawsuit is blaming for the death of a California woman.
The lawsuit, filed by the woman’s family in Los Angeles, said her death was caused by use of the Infuse spinal graft in her neck. The device is approved only for use in lower-back surgery and some oral and dental procedures.
The woman’s surgery took place in August, a month after the Food and Drug Administration warned that use of Infuse for neck surgeries had led to problems swallowing, breathing and speaking.