Record number:
407
Adverse Occurrence type:
MPHO Type:
Time to detection:
79 months
Alerting signals, symptoms, evidence of occurrence:
Spain case 3: in 1991, an 18-year-old man developed ataxia, dysmetria, dysarthria, and generalized hyperreflexia 79 months (6 1/2 years) after a posterior fossa craniectomy for a cerebellar astrocytoma; using a LYODURA dura allograft graft. Subsequently he became mute with decorticate posture and myoclonic movements of all four limbs. A cerebral biopsy was consistent with CJD. He died 3 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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