MAUDE Adverse Event Report: Dentsply IH AB PrimeTaper EV Ø4.8 x 9mm OS; implant, endosseous, root-form

Lot Number	507485
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant breakage.The dental implant was explanted as a result.

• Brand Name: PrimeTaper EV Ø4.8 x 9mm OS
• Common Device Name: implant, endosseous, root-form
• Manufacturer (Section D): Dentsply IH AB; aminogatan 1; molndal vastra gotalands lan S-431 21; SW S-431 21
• Manufacturer Contact: mr. dan eagar; suite 60w; york, PA 17401
• MDR Report Key: 50757011
• Report Number: 9612468-2026-08142
• Device Sequence Number: 15751868
• Product Code: DZE
• UDI-Device Identifier: 07392532276781
• UDI-Public: 07392532276781
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K210610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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?: Yes
• Device Lot Number: 507485
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown