MAUDE Adverse Event Report: COLTENE WHALEDENT INC. PARAPOST FIBER LUX; POST, ROOT CANAL

Catalog Number	PF1714
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burning Sensation (2146); Discomfort (2330); Insufficient Information (4580)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), coltene recieved a report from a patient expalining that after 2 1/2 years of a burning sensation, she voluntarily had a dental implant using coltene's post along with another manufacturer's post and core material removed due to an allergic reaction.The patient said she had extensive allergy testing, which led to a double positive reaction to titanium dioxide and was inquiring whether or not coltene's product number pf1714 contained titanium dioxide.No batch number was given nor available.Additional information for other compounds used in the patient's procedure was attempted but not received.Coltene product number pf1714 does not contain titanium dioxide.
Additional Manufacturer Narrative
At the time of the inital report, additioanl information was sought since the allergic reaction was identified by the patient as titanium dioxide.Since coltene's product doe not contain titanium dioxide, the investigation concluded the cause of the allergic reaction must have been another source of material used in the dental restoration procedures but was unable to confirm.

• Brand Name: PARAPOST FIBER LUX
• Common Device Name: POST, ROOT CANAL
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer (Section G): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer Contact: leslie brazina ; 235 ascot parkway; cuyahoga falls, OH 44223 ; 3309168838
• MDR Report Key: 23617222
• Report Number: 2416455-2025-00001
• Device Sequence Number: 10072692
• Product Code: ELR
• UDI-Device Identifier: D661PF17141
• UDI-Public: D661PF17141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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 Catalogue Number: PF1714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female