Manufacturing site evaluation: device - reference code 1067010.Device name lyoplant onlay 2.5x2.5cm.Serial number n/a.Batch number 218443.Udi device identifier (b)(4).Udi production identifier 218443.Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 16.11.2018.The product is not available for investigation.Date of occurrence: (b)(6) 2019 customer: anonymous.Pictorial documentation - 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).Corrective action : 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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