MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH XIVE S PLUS IMPL D3.8/L15; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	26-2445
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Osteolysis (2377)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

• Brand Name: XIVE S PLUS IMPL D3.8/L15
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23638239
• Report Number: 3013111692-2025-33446
• Device Sequence Number: 13076135
• Product Code: DZE
• UDI-Device Identifier: 07392532208881
• UDI-Public: 07392532208881
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• 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): 11/24/2025

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: 26-2445
• Device Lot Number: B120005349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NOT PROVIDED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown