MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. ATL BRIDGEBASE TI AM 4 IMP; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	68022544
Medical Device Problem Code	Fracture (1260)
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 and digital design file and both been reviewed and show no anomalies.We are awaiting the return of the device to complete our investigation.The associated implant loss event was reported under mfr report # 3013111692-2025-12178.
Event or Problem Description
It was reported that an alantis bridgebase ti am 4 implants fractured and resulted in implant loss.

• Brand Name: ATL BRIDGEBASE TI AM 4 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: 22017790
• Report Number: 3007362683-2025-00008
• Device Sequence Number: 15823564
• Product Code: NHA
• UDI-Device Identifier: 07392532257339
• UDI-Public: 07392532257339
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193064
• 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): 05/14/2025

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: 68022544
• Device Lot Number: 9122585
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNI ABUTMENT REF NUMBER: 25558 - LOT NUMBER: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown