MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH MULTIBASE AB EV (S) 3.5MM 17°; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	68012180
Medical Device Problem Codes	Fracture (1260); Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
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 was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.
Additional Manufacturer Narrative
Additional information received from customer.Implant loss was mistaken reported.The abutment would not lock in and broke.This is a follow up report for this additional information.Device received for this event is being corrected from unknown atis ev implant catalog # unk atis ev implant to multibase ab ev (s) 3.5mm 17° catalog # 68012180.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, 1863.Investigation findings code, 3221.The correct codes for this complaint are: health effect, clinical code, 4582.Health effect, impact code, 2199.Medical device problem code, 1260.Investigation findings code, 3252.This is a follow up report to correct these/this code(s).

• Brand Name: MULTIBASE AB EV (S) 3.5MM 17°
• 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: 24053276
• Report Number: 3013111692-2026-02045
• Device Sequence Number: 9883598
• Product Code: DZE
• UDI-Device Identifier: 07392532278518
• UDI-Public: 07392532278518
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 68012180
• 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: 01/13/2026
• 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: (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown