MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH FRI ESTHETICBASED 3.4/GH 1/A 0; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	32462131
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
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 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 fracture.The dental implant was explanted as a result.
Additional Manufacturer Narrative
Device received for this event is being corrected from unknown frialit implant catalog # unk frialit implant to fri estheticbased 3.4/gh 1/a 0 catalog # 32462131.This is a follow up report for this corrected information.Correcting udi # from ni to (b)(4).This is a follow up report for this corrected information.This is to correct and remove the codes that were initially reported, removing codes for: health effect, clinical code, 1924.Health effect, impact code, 4621.Medical device problem code.Investigation findings code, 3243.The physical investigation of the returned items revealed that fracture had occurred.The correct codes for this complaint are: health effect, clinical code, 4582.Health effect, impact code, 2199.This is a follow up report to correct these/this code(s).

• Brand Name: FRI ESTHETICBASED 3.4/GH 1/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
• MDR Report Key: 24069390
• Report Number: 3013111692-2026-02334
• Device Sequence Number: 15797847
• Product Code: DZE
• UDI-Device Identifier: 07392532230516
• UDI-Public: 07392532230516
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,Followup
• Report Date (Section B): 01/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 32462131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/23/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/27/2026
• 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: 32462131 FRI ESTHETICBASED 3.4/GH 1/A 0.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown