MAUDE Adverse Event Report: ODNE AG ODNECLEAN

Model Number	E-0003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Post-operative pain and flare-ups are know side effects of endodontic treatments used to treat a severe infection inside the tooth and the apical tissue and bone.Cases of severe pain or swelling are less common but still happen.It is suspected that the severe reaction in this case might have been caused by the absence of cortical bone surrounding the apex of the distal root (as reported by the surgeon who extracted the tooth), which could have allowed infected debris to be flushed into the soft tissues and triggered an acute inflammatory response.The medical device used (odneclean) performed normally and as intended.It cannot be concluded if the device contributed to the adverse event or not.
Event or Problem Description
Patient received initial root canal treatment on tooth #31.3 days following treatment he began to develop some swelling.On day 5 the patient had worsening trismus.Endodontist instructed him to go to the emergency room for a ct scan.A lateral pharyngeal space infection was noted and the oral surgeon on staff extracted the tooth.A small amount of pdl (periodontal ligament) widening was noted around the apex of the d (distal) root with a slight perforation of the lingual cortical plate.

• Brand Name: ODNECLEAN
• Common Device Name: ODNECLEAN
• Manufacturer (Section D): ODNE AG; ringstrasse 14; duebendorf, zh 8600 ; SZ 8600
• Manufacturer (Section G): ODNE AG; ringstrasse 14; duebendorf, zh 8600 ; SZ 8600
• Manufacturer Contact: mark bispinghoff ; ringstrasse 14; duebendorf, zh 8600 ; SZ 8600
• MDR Report Key: 25652841
• Report Number: 3030405669-2026-00003
• Device Sequence Number: 14919497
• Product Code: ELC
• UDI-Device Identifier: 07649988156632
• UDI-Public: 7649988156632
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K233844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: Health Professional
• Device Model Number: E-0003
• Device Catalogue Number: E-0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male