The FDA said it's aware that Stryker has issued letters to affected customers recommending certain TMJ Unilateral and Bilateral Implants have updated instructions for use.
The company said it received a report that during surgery to implant the device, a 6mm screw was placed in an approximately 2.6mm thick bone, which penetrated the cranial vault.
There is a discrepancy in the positioning of the screw hole between what was specified in the design specification sheet and the actual fossa design. This may result in the recommended screw length being greater than the bone thickness for implants with screw holes located in an area of thin bone and penetration of the cranial vault. Penetration of the cranial vault could lead to dural tissue damage, bleeding, cerebral spinal fluid leak (CSF), or meningitis. Use of an affected device could require intervention to prevent serious injury.
As of December 4, Stryker has reported one serious injury and no deaths associated with this issue.
