MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH FRI ESTHETICBASED 3.0/GH 5/A 0; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	32462125
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.
Event or Problem Description
It was reported that a patient experienced a dental implant loss due to fracture of implant.
Additional Manufacturer Narrative
Adding additional information received: we received an implant and abutment d3,0, which were placed in a contraindicated position.The optical investigation showed, that the implant is not fractured, but was damaged during removal.Removal was assumably due to the fracture of the abutment.This is a follow up report for this additional information.Additional fda coding being added after investigation of device.Adding additional health effect - impact code: 4627.This is a follow up report to add this additional code.Additional fda coding being added after investigation of device.Adding additional medical device problem code: 1494.This is a follow up report to add this additional code.Additional fda coding being added after investigation of device.Adding additional type of investigation code 10.This is a follow up report to add this additional code.Additional fda coding being added after investigation of device.Adding additional investigation findings: 4248.This is a follow up report to add this additional code.Additional fda coding being added after investigation of device.Adding additional investigation conclusions: 24.This is a follow up report to add this additional code.Device received for this event is being corrected from xive s plus impl d3.4/l13 catalog # 26-2433 to fri estheticbased 3.0/gh 5/a 0 catalog # 32462125.This is a follow up report for this corrected information.Correcting udi # from (b)(4) to (b)(4).This is a follow up report for this corrected information.Correcting concomitant medical products from 32462135 to xive implant 32262412.This a follow up report for this corrected information.

• Brand Name: FRI ESTHETICBASED 3.0/GH 5/A 0
• 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: 22639786
• Report Number: 3013111692-2025-20680
• Device Sequence Number: 21256504
• Product Code: DZE
• UDI-Device Identifier: 07392532230509
• UDI-Public: 07392532230509
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K073075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 32462125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/16/2025
• 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: 32462135.; XIVE IMPLANT 32262412.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown