MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC AH PLUS BIOCERAMIC SEALER STARTER KIT; RESIN, ROOT CANAL FILLING

Catalog Number AHPBIOSEAL

Device Problem Overfill (2404)

Patient Problem Abscess (1690)

Event Date 04/11/2022

Event Type  Injury  

Event Description

Doctor was trying our new sealer, ah plus bioceramic and was working on #19, which had an abscess.He also thinks it has a vertical root fracture.He performed an endo and was using our sealer to obturate with a single cone.He said the sealer didn't push back coronally like he normally would see, so he extruded more.Looking at the final x-ray, he became concerned because the sealer looks like it penetrated the bone.Apparently there's a significant extrusion.The sealer is usually tolerated very well by the surrounding tissue, so he should continue monitor the patient and follow up.The ifu indicates for large amounts the material should be removed, however, it this case it is not possible.

• Brand Name: AH PLUS BIOCERAMIC SEALER STARTER KIT
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• MDR Report Key: 14106501
• MDR Text Key: 289225599
• Report Number: 2320721-2022-00151
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/13/2022

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?: Yes
• Device Catalogue Number: AHPBIOSEAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2022
• Distributor Facility Aware Date: 04/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other