Record number:
409
Adverse Occurrence type:
MPHO Type:
Estimated frequency:
Authors estimate that the incidence of CJD after dura use was 1 per 1250 recipients.
Time to detection:
1.2 - 24.8 years
Alerting signals, symptoms, evidence of occurrence:
A survey of CJD cases in Japan showed that 132 were dura associated (Lyodura), receiving Lyodura between 1978 and 1993 and 120 of them received dura allograft between 1983-1987. Individual case histories were not reported but the incubation period from surgery to first symptoms was 11.8 yr (mean), 12.4 yr (median) and the range was 1.2 to 24.8 yr. The mean age was 55 yr (range 15-80) and 60% of patients were female.
Demonstration of imputability or root cause:
Level 4. Certain. Lyodura has been well known to be contaminated by prions and cause CJD during the period when the German manufacturer (Braun) pooled dura from many donors during processing, did not screen to exclude high risk donors, did not treat with 1% sodium hydroxide. No donor information available. Most recipients had a clinical diagnosis of CJD but 23% had a brain tissue sample tested histologically.
Imputability grade:
3 Definite/Certain/Proven
Keywords:
References:
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