MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC ENDO ACCESS -X GATES; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	XGATE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
C/n: 411578-1, xgate, lot: 1871660, 2 packs.Customer has broken approximately 2 packs of xgates during use.No patient injury.They did not save the broken instruments.Replacing with 2 packs.
Additional Manufacturer Narrative
Here has been a previous report received for a similar device 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.Customer discarded, nothing to return.No other complaints for lot number.Product not received at investigation site.Failure mode: broken during use.Root cause: product not received at investigation site.Conclusion code: indeterminable.

• Brand Name: ENDO ACCESS -X GATES
• Common Device Name: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• 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 ; 7178457511
• MDR Report Key: 20734733
• Report Number: 2320721-2024-00070
• Device Sequence Number: 15525733
• Product Code: NDP
• UDI-Device Identifier: D716XGATE1
• UDI-Public: D716XGATE1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: XGATE
• Device Lot Number: 1871660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown