Implant traceability is ensured by a set of adhesive labels provided with the implant, bearing information such as name or commercial model, manufacturer or importer information, product code, batch number and ANVISA registration number. The product is supplied with 4 traceability labels.
Therefore, it is possible to follow the path back to production, raw materials, suppliers and other quality control items established in Resorba Medical general quality plan.
Physicians must advise patients to keep the report they are given after surgery and tell them the report provides details on the product implanted. The labels are intended to act as traceability tools for the implant.
In case of any adverse effect, physicians or patients should report it to the product distributor in Brazil and to the competent health authority, the Brazilian Health Surveillance Agency at www.anvisa.gov.br.