Fernando Cluster went to Emory University Hospital Midtown in Atlanta, Georgia, with a brain bleed in September 2022. It was serious: they needed to remove part of his skull temporarily, to give his brain space to swell and heal.
But when he went into surgery again six weeks later for surgeons to replace the skull piece – the size of a saucer, about 11.5cm by 15cm (4.5 inches by 6 inches) – the hospital could not find it.
The surgery was cancelled. What came next was several days of waiting, as Emory had to order a synthetic replacement to be produced in the exact shape of the missing piece, called a “bone flap”.
After he received the skull implant, Cluster developed an infection, which the lawsuit calls a known complication that can arise from a synthetic implant.
Cluster and his wife have now filed a lawsuit asking the courts to order Emory to compensate them for injuries and damages. In addition to the cost of his surgery, the lawsuit says Emory has charged US$146,845.60 for things that were a direct result of their mistake. That includes more than US$19,000 for the synthetic skull implant itself.
I’m sure you can understand that their focus is on the egregiousness of Emory losing a part of his body and then having a flippant attitude about it afterwards
According to documents the Clusters assembled for the lawsuit, Emory doctors added a note to Cluster’s medical file explaining the events of the day his surgery was cancelled: “Although we were informed yesterday by OR [operating] staff that Mr. Cluster’s bone flap was located and ready for replacement, it could not be found today when preparing for surgery.
“We inspected the freezer where bone flaps are stored and could not find a bone flap with Mr Cluster’s patient identification. There were several bone flaps with incomplete or missing patient identification, but we could not be certain which if any of these belonged to Mr Cluster.
“As a result we unfortunately were forced to cancel the surgery. The circumstances of the cancellation were discussed in detail with the patient, his spouse [who was present] and other family over the phone. They were understandably upset by the situation and we encouraged them to reach out to patient advocacy.”
Chloe Dallaire, the Clusters’ lawyer in the case, said Emory never offered a discount as a result of the mistake. His medical insurance through his wife’s employer paid most of the cost.
“While my clients are obviously upset that they and their insurance company were billed for the costs related to Emory’s negligence, I’m sure you can understand that their focus is on the egregiousness of Emory losing a part of his body and then having a flippant attitude about it afterwards,” Dallaire said.
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Asked for a response, a spokeswoman for Emory said it does not comment on pending litigation.
“Emory Healthcare is committed to providing high-quality, compassionate care for patients and those we serve in our communities,” spokeswoman Jennifer Phillips said.
Decades ago the handling of bone implants within hospitals was barely regulated, and doctors could rely on their own storage and judgment, which sometimes resulted in dangerous mistakes. Implants of bone and other tissue are now regulated by the US Food and Drug Administration.
According to the American Association of Tissue Banks, there are federal regulations that require tracking of tissue when it is taken from one person to be implanted in another, for transplant.
That lasts only up until the moment when it’s given to the hospital or clinic where it is to be implanted. Then, the hospital must follow more standards for the implantation.
According to the AATB’s website, it is “critical for healthcare facilities to have systems” in place to track implants, such as bar codes containing unique identifiers.