It was reported that there was an issue with 1067040 - lyoplant onlay 7.5x7.5cm.According to the complaint description, the surgeon placed lyoplant onlay on a patient, and the patient developed a pseudomeningocele and chemical meningitis.He took the patient back to the operation room, 3 1/2 months after initial implantation, thinking maybe a suture had come lose.However, the sutures were all in place and there was a dehiscence of the lyplant onlay and cerebrospinal fluid (csf) was leaking out".A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).
|
Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
|