FDA 483 - Argon Medical Productions & Vertrieb Gesellschaft MBH & CO

Argon Medical Productions & Vertriebs Gesellschaft MBH & Co, a device manufacturer in Bingen Am-Rhein, Germany, was cited for significant deficiencies in its post-market surveillance and quality system. Observations included a lack of written Medical Device Reporting (MDR) procedures, failure to submit an MDR report for serious injuries related to dental implant failures, and issues with Unique Device Identifier (UDI) labeling and database registration. Additionally, the firm failed to investigate complaints involving device failures.