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Custom Cranial Implants

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.
Malfunctions:
  • 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.
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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. 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. read more

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Custom Cranial Implants News Articles

Vs. battle's News Archive

Surgery stops screaming pain of trigeminal neuralgia | Cincinnati.com | cincinnati.com

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Custom Cranial Implants Newsfeeds

Stryker Working to Resolve FDA Warning Letters

LegalView Developing Cranial Implant Information Portal Detailing the Recall of Stryker Cranial Implant Kits

View the Custom Cranial Implants Newsfeeds page here

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