Device name: Stryker Custom Cranial Implant Kits
Manufacturer: Stryker Corporation
Approved uses: Custom cranial implant is designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face.
Potential contamination, compromising the sterile nature of the implant and potentially resulting in infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly.
Stryker Custom Cranial Implant Kits
Stryker’s Craniomaxillofacial (CMF) business unit announced that the U.S. Food and Drug Administration (FDA) decided on Dec. 18, 2008 that its recall of the following Stryker CMF’s Custom Cranial Implant Kits is a Class I recall, meaning the product could pose an imminent hazard to health. The FDA’s announcement comes after a voluntary recall issued by the company in October of 2008, following concerns that stereilization of the implants could not be guaranteed. Implantation of contaminated devices could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly.
Stryker CMF previously notified implanting surgeons, hospital risk managers and its sales representatives of the potential health risks associated with the kits and requested that they return any remaining products to the company. They will again notify hospital staff and surgeons of this recall and its potential health risk and request that physicians or hospitals return to Stryker CMF any of this product that has not been implanted.
The Use of Cranial Implants In The United States
Cranial implants are used for an array of face, jaw and cranium defects among a variety of patients in the United States. Cranial defects can develop in several ways. Some of the following are conditions that often require the implementation of a cranial implant kit.
• birth defects/complications
• traumatic brain injury
• cranial abnormalities
• orbital roof or medial wall defects
• brain hemorrhaging
• soft tissue loss
• scalp swelling
One such defect that is commonplace in requiring a cranial implant kit is that of temporomandibular joint, or TMJ of the jaw joint, which occurs as a “collection of poorly understood conditions characterized by pain in the jaw and surrounding tissues and limitations in jaw movements,” according to the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health.
TMJ can be caused by injuries that regularly cause damage and pain to other parts of the body including Arthritis. The NIDCR has said that TMJ affects nearly 10 million Americans, both men and women, “at any given time,” but predominately is seen among women who are within their “childbearing years.”
Cranial Implant Recall
The technology for which cranial implant kits are created is quite advanced and often kits are specially designed and cut for an individual, which makes it even more difficult for such products to be recalled as surgery is often required. According to a recent U.S. Food and Drug Administration’s (FDA) medical announcement, “custom cranial implants are designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face.” Unfortunately, one such recall has recently occurred among the Stryker Corporation’s Custom Cranial Implant Kits.
Approximately 322 patients will likely be affected by the cranial implant kit recall, which occurred after issues with the kit’s sterility arose. If a patient does nothing about the recall, the result may be fatal or cause severe injury to a cranial implant kit patient.
Those who have been affected by the cranial implant kit recall should discuss the development of a cranial implant kit lawsuit by speaking with an experienced medical attorney who can provide a free legal consultation for those endangered by the Stryker cranial implant kit risks. Additionally, by contacting an experienced medical injury attorney, the chances of earning monetary compensation for the injuries incurred are increased for a cranial implant kit recall victim.