MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH COMPETITOR UNKNOWN PRODUCT IMPLANTS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	COMPETITOR UNKNOWN PRODUCT IMP
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/10/2026
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
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Additional information received; update information was received which indicated that this is not a reportable event.Product 24191 profile biabut 4.0 -ø5.5 is the concomitant product for case(b)(4).Please send an update to the fda to disregard this report.This follow up report is to correct this event to a non-reportable.This report was submitted in error.Please disregard the initial report.Device received for this event is being corrected from profile biabut 4.0 -ø5.5 catalog #24191 to competitor unknown product implants catalog # competitor unknown product implants.This is a follow up report for this corrected information.

• Brand Name: COMPETITOR UNKNOWN PRODUCT IMPLANTS
• 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: 24437142
• Report Number: 3013111692-2026-07102
• Device Sequence Number: 18718086
• Product Code: DZE
• UDI-Device Identifier: 07392532036897
• UDI-Public: 07392532036897
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K974738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 02/27/2026

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: COMPETITOR UNKNOWN PRODUCT IMP
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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: NOT PROVIDED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown