MAUDE Adverse Event Report: DEGRADABLE SOLUTIONS AG GUIDOR; EASY-GRAFT CLASSIC

Model Number	C11-078
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/18/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor had placed the product in a premolar that was missing a bony wall.After two weeks the patient contacted the doctor and informed him that the site is swollen & infected.Patient was in a lot of pain.As per doctor, a handling of the product was fine and the site was not overfilled by the product.The patient has no known allergies.Doctor removed the product from the site.Complaint # (b)(4).

• Brand Name: GUIDOR
• Common Device Name: EASY-GRAFT CLASSIC
• Manufacturer (Section D): DEGRADABLE SOLUTIONS AG; wagistrasse 23; schlieren zurich, 8952 ; SZ 8952
• MDR Report Key: 5869020
• Report Number: 0001413787-2016-00002
• Device Sequence Number: 466450
• Product Code: LYC
• UDI-Device Identifier: 07640164360096
• UDI-Public: 07640164360096
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/11/2016
• Report Date (Section F): 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dentist
• Device Model Number: C11-078
• Device Lot Number: 15-199
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/20/2016
• Event Location: Other
• Date Report to Manufacturer: 08/11/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other