Record number:
406
Adverse Occurrence type:
MPHO Type:
Time to detection:
43 months
Alerting signals, symptoms, evidence of occurrence:
Spain case 2: in 1987, a 57-year-old woman was hospitalized for gait ataxia, dysarthria, dizziness, and bilateral hypertonus 43 months following surgery for Arnold-Chiari malformation using dura mater allograft (LYODURA). Two weeks after hospitalization, she became demented and showed facial and limb myoclonic movements. A right frontal cerebral biopsy was consistent with CJD. She died 25 months after clinical onset. The patient was one of over a hundred others dying of CJD acquired from contaminated dura (LYODURA) made by pooled processing by Braun, Germany
Demonstration of imputability or root cause:
Level 4. Certain. Although no clinical information was known about the donor, the patient was one of over a hundred others worldwide dying of CJD acquired from contaminated freeze-dried dura mater allograft , LYODURA brand, made by pooled processing involving dura from many inadequately screened donors by B. Braun Melsungen AG, Germany
Imputability grade:
3 Definite/Certain/Proven
Keywords:
References:
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