It was reported that there was an issue with a lyoplant onlay implant, per information from medwatch 5092427.According to the reporter the patient underwent chiari decompression with use of a lyoplant graft, and returned to hospital with aseptic meningitis sometime later.This serious injury had the outcome of hospitalization.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
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Customer: anonymous investigation results: no product available for investigation.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Therefore, the root cause of the error is most probably patient or usage related.Rationale: no causality between the product and the mentioned issue can be found.An infection of the patient that already existed before the surgery cannot be excluded.Contraindications and warnings can be found in the instructions for use (ifu).According to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.
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