MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) COMPETITOR UNKNOWN PRODUCT IMPLANTS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	COMPETITOR UNKNOWN PRODUCT IMP
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Additional information received that this was entered in error as this is a duplicate report for mdr # 9612468-2025-01965.This follow up report is to report that this mdr is a duplicate of mdr # 9612468-2025-01965.Please disregard this report due to this being a duplicate report.Device received for this event is being corrected from primetaper ev ø5.4 x 11mm os catalog # 68011113 to competitor unknown product implants catalog # competitor unknown product implants.This is a follow up report for this corrected information.Removing unique identifier (udi) # (b)(4).This is a follow up for removing the udi #.

• Brand Name: COMPETITOR UNKNOWN PRODUCT IMPLANTS
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24071188
• Report Number: 9612468-2026-00219
• Device Sequence Number: 9380641
• Product Code: DZE
• UDI-Device Identifier: 07392532276866
• UDI-Public: 07392532276866
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Health Professional
• 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: COMPETITOR UNKNOWN PRODUCT IMP
• Device Lot Number: 512519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/07/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• 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: ABUTMENT + HEALCAP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown