MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ASTRATECH IMPL EV 5.4S 6MM OS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	26360
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/06/2024
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.According to russian regulation, these products are considered unsafe and hazardous, therefore ds llc is not allowed to ship them.The products must be terminated by a special company, that has a license for that kind of activity & type of hazardous goods.

• Brand Name: ASTRATECH IMPL EV 5.4S 6MM 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: 24823606
• Report Number: 3013111692-2026-11635
• Device Sequence Number: 17630418
• Product Code: DZE
• UDI-Device Identifier: 07392532214523
• UDI-Public: 07392532214523
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K120414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 04/08/2026

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: 26360
• Device Lot Number: 514301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/08/2026
• 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