MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ASTRATECH IMPL EV 3.0S 8MM OS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number	N/A
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event 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.
Event or Problem Description
Customer reported implant loss.¿catastrophic bone loss around implant 2 months placement.Placed on (b)(6) 2025 with cover screw.Seen patient on (b)(6) 2026 month review, if radiograph had been ok would have arranged to replace cover screw with healing abutment.Pa attached.Showed significant bone loss.Discussed with implant mentor, (b)(6) , both felt explanation was best, with intention to have another attempt at placement in a couple of months.¿.

• Brand Name: ASTRATECH IMPL EV 3.0S 8MM OS
• 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: 24226111
• Report Number: 3013111692-2026-04337
• Device Sequence Number: 15762477
• Product Code: DZE
• UDI-Device Identifier: 07392532214127
• UDI-Public: 07392532214127
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 01/30/2026

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 Model Number: N/A
• Device Catalogue Number: 26301
• Device Lot Number: 499841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/26/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/30/2026
• 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: NOT PROVIDED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown