MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ASTRATECH IMPL EV 5.4S 13MMOS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	26364
Medical Device Problem Codes	Failure to Osseointegrate (1863); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.No information besides implant failure was received so far.Additional information and product return is requested.Follow-up report will be sent in case additional information will be received.Trend is tracked and monitored.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Adding additional information - adding udi # (b)(4).Adding implanted date (b)(6) 2024.Adding explanted date (b)(6) 202.This is a follow up report for this additional information.Device received for this event is being corrected from unknown atis implant catalog # unk atis implant to astratech impl ev 5.4s 13mmos catalog # 26364.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 - remove 4580 medical device problem code remove 3190 the correct codes for this complaint are: medical device problem code - add 1863 this is a follow up report to correct this code.Correcting lot # from unk to lot # 517630.This is a follow up report for this corrected information.

• Brand Name: ASTRATECH IMPL EV 5.4S 13MMOS
• 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: 21847709
• Report Number: 3013111692-2025-11140
• Device Sequence Number: 8608060
• Product Code: DZE
• UDI-Device Identifier: 07392532214561
• UDI-Public: 07392532214561
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 26364
• Device Lot Number: 517630
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown