MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC GUTTA-SMART CONFORM FIT GP CRTG 23G; GUTTA-PERCHA

Catalog Number	GSMART23G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that gutta-smart conform fit gp crtg 23g is said to exploded in flow handpiece and in patient's tooth #46.This fractured the tooth.The outcome of this event is unknown as of this mdr.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative
No product being returned for investigation.Customer discarded product.No lot number provided.

• Brand Name: GUTTA-SMART CONFORM FIT GP CRTG 23G
• Common Device Name: GUTTA-PERCHA
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401
• MDR Report Key: 21864285
• Report Number: 2320721-2025-00061
• Device Sequence Number: 4592117
• Product Code: EKM
• UDI-Device Identifier: D716GSMART23G1
• UDI-Public: D716GSMART23G1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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?: Yes
• Device Catalogue Number: GSMART23G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown