MAUDE Adverse Event Report: AMANN GIRRBACH AG CERAMILL ZOLID; CERAMILL ZOLID FX ML

Model Number	761810 ZOLID FX ML D2/D3 98X20N
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Summary: during production, blanks with surface inclusions were discovered after sintering in one order.After an edx analysis was performed on the inclusions, it was confirmed that they were metallic particles.This confirmed the suspicion that the particles originated from the press itself, caused by a crash on the press, which was documented.Thus, affected orders could be identified and rechecked.From the affected batches, (b)(4) blanks could still be blocked before delivery.According to the system, (b)(4) blanks have already been delivered to intermediate storage.Of these, (b)(4) blanks have already been delivered to customers.Risk assessment & decision: in the case of the affected delivered products, there is a potential risk of contamination by metallic foreign particles, which could influence the esthetic as well as mechanical properties of the final product (dental restoration).The probability of detection during processing is considered to be very good.Nevertheless, there is no fully comprehensive security for this.In addition, product conformity cannot be guaranteed.Therefore, all produced and potentially contaminated products must be scrapped.Products that have already been delivered must be retrieved and also disposed of.After thorough examination and detailed investigation of the causes, it can be proven with certainty that the contamination is purely superficial.Since the surface of the blanks is always milled off in a safe manner due to the machining process, it can be guaranteed that there is no contamination in the dental restorations produced and therefore no increased risk for patients.Official safety information has been prepared for this purpose (field safety notice).A capa has been initiated for the definition of suitable remedial measures.Note: no potentially non-conforming product was delivered to end users or patients in the usa.

• Brand Name: CERAMILL ZOLID
• Common Device Name: CERAMILL ZOLID FX ML
• Manufacturer (Section D): AMANN GIRRBACH AG; herrschaftswiesen 1; koblach, vorarlberg 6842 ; AU 6842
• MDR Report Key: 11824905
• Report Number: 3006206552-2021-00003
• Device Sequence Number: 14544223
• Product Code: EIH
• UDI-Device Identifier: E4947618101
• UDI-Public: E4947618101
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K152383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/24/2026
• Device Model Number: 761810 ZOLID FX ML D2/D3 98X20N
• Device Catalogue Number: 761810
• Device Lot Number: 2103001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1