A Pennsylvania woman says that a surgical screw made by a Michigan company and implanted in her lumbar vertebrae during spinal fusion surgery has fractured and can’t be removed safely.
Donna Mae Dolby of Lower Burrell, Pennsylvania filed suit in Allegheny County Court of Common Pleas against Stryker Corporation of Portage, Michigan and the Allegheny Health Network (doing business as “Allegheny Valley Hospital”) and Greater Pittsburgh Orthopaedic Associates, Inc. (GPOA), both of Pittsburgh.
Background
In 2010, Donna Dolby saw the surgeons at Greater Pittsburgh Orthopaedic Associates for lower back pain. They determined that she needed lumbar fusion surgery at L4-L5. The operation was done September 15, 2010 at the Allegheny Valley Hospital. The surgery was successful, and the fusion at L4-5 became intact. The orthopaedic surgeons installed surgical screws into the patient’s L5 vertebrae during this procedure.
These surgical screws installed were designed, manufactured, and distributed by Michigan’s Stryker Corporation. In 2016, Ms. Dolby started to have spinal instability and more spine pain. Because of this, GPOA performed a bilateral lumbar laminectomy, L2-L3 with postereolateral mass fusion of L2-L4 with Z instrumentation L2-L4 with metal removal L4-5 in March 2016. Some instrumentation was removed from her spine, but other medical instrumentation remained or was placed into Ms. Dolby’s L5 vertebrae.
The medical parts installed during the second procedure included surgical screws that were also designed, manufactured and distributed by Stryker. This surgery was successful, the complaint said, and the patient’s radiculopathy was significantly better—but not completely eliminated—after the procedure.
However, in early May of 2022, the patient felt a sharp increase in her lower back pain and symptoms.
The Screw Breaks, and the Patient Files Suit
On May 12, 2022, a lumbar X-Ray showed that one of the pedicle screws located in Ms. Dolby’s L5 vertebrae had broken in half.
The patient claimed that this fractured pedicle screw was the cause of her increased lower back symptoms. She sought additional medical care in an effort to remove the broken screw. Unfortunately, she was told that it would be impossible to remove the broken screw without causing extensive and life-lasting damage to her lumbar spine.
As a result, Ms. Dolby claims she will spend the rest of her life with increased disability. The complaint says that she’ll “endure intense pain and suffering for the remainder of her life.”
In addition, she’s incurred and will continue to incur medical expenses.
As a result of the broken screw, her husband Eric (who is also a plaintiff), claims that he’s lost the care and support of his spouse.
The complaint includes causes of action for strict liability, breach of warranty, and negligence.
The Stryker Corporation was founded by Dr. Homer Stryker, an orthopaedic surgeon from Kalamazoo, Michigan in 1941.
