MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. ATL BRIDGEBASE TI AM 6 IMP; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	68022546
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.The dhr review and the investigation of the digital design file did not reveal anomalies.Scan comparison between original and model for the remake shows analog position #4/15 is lost.There is deviation on the height of the scan flag positions in the front and in direction on all scanflag positions.
Event or Problem Description
In this event it is reported that a atl bridgebase ti am 6 imp fractured between tooth #12 and 13.One implant was lost.

• Brand Name: ATL BRIDGEBASE TI AM 6 IMP
• Common Device Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg B-350 0; BE B-3500
• Manufacturer (Section G): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg B-350 0; BE B-3500
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 21984426
• Report Number: 3007362683-2025-00007
• Device Sequence Number: 4311714
• Product Code: NHA
• UDI-Device Identifier: 07392532257339
• UDI-Public: 07392532257339
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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
• Device Catalogue Number: 68022546
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown