Record number:
408
Adverse Occurrence type:
MPHO Type:
Time to detection:
105 months
Alerting signals, symptoms, evidence of occurrence:
Spain case 4: in 1992, a 34-year-old man reported dizziness and slurred speech 105 months (8 3/4 years) after surgery for Arnold-Chiari malformation and syringomyelia using LYODURA dura allograft graft. He also had ataxia, nystagmus, mild hyperreflexia, and bilateral pale optic discs and rapidly progressed to mutism, and decorticate posturing with myoclonic movements in all four limbs. A brain biopsy was consistent with CJD. 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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