Adverse Occurrence type:
Time to detection:
Alerting signals, symptoms, evidence of occurrence:
A 35 year old man received a Lyodura dura allograft in 1991 during surgical repair of a skull fracture. In 1997, 79 months later, he developed unsteady gait, dysmetria, dyskinesia, and myoclonic jerks and died 4 months after onset of symptoms of CJD proven at autopsy.
Demonstration of imputability or root cause:
Level 3. Likely, probable transmission. Although no clinical information was known about the donor, the dura recipient died of autopsy-proven CJD and was one of over a hundred others worldwide dying of CJD acquired from contaminated freeze-dried, Lyodura brand, dura mater allograft made by pooled processing involving dura from many inadequately screened donors by B. Braun Melsungen AG, Germany