MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) PRIMETAPER EV Ø4.2 X 15MM OS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	68011101
Medical Device Problem Codes	Mechanical Problem (1384); Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Dentsply sirona became aware of a serious injury with an implant due to a malfunction of a bone reamer guide that occurred while using the primetaper implant system.This report is for the dental implant device.The bone reamer guide report was submitted under mfr report # xxxxxxx.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.
Additional Manufacturer Narrative
Additional fda coding being added after investigation of device.Adding additional type of investigation code 10.This is a follow up report to add this additional code.This is to correct and remove the codes that were initially reported - removing codes for: health effect - impact code - 4627 medical device problem code - 2547 investigation findings code - 3253 investigation conclusions code - 4322 the physical investigation of the returned items revealed that no fracture had occurred.The correct codes for this complaint are: health effect - impact code - 4621 and 4625 medical device problem code - 2976 and 1384 investigation findings code - 3243 and 114 investigation conclusions code ¿ 61 this is a follow up report to correct these/this code(s).

• Brand Name: PRIMETAPER EV Ø4.2 X 15MM OS
• 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: 23290331
• Report Number: 9612468-2025-01883
• Device Sequence Number: 4824208
• Product Code: DZE
• UDI-Device Identifier: 07392532276743
• UDI-Public: 07392532276743
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 68011101
• Device Lot Number: 533143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/18/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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