MAUDE Adverse Event Report: Dentsply IH AB PrimeTaper EV Ø4.8 x 13mm OS; implant, endosseous, root-form

Catalog Number	68011107
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury

• Brand Name: PrimeTaper EV Ø4.8 x 13mm OS
• Common Device Name: implant, endosseous, root-form
• Manufacturer (Section D): Dentsply IH AB; aminogatan 1; molndal 431 2 1; SW 431 21
• Manufacturer (Section G): Dentsply IH AB; aminogatan 1; molndal 431 2 1; SW 431 21
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50744295
• Report Number: 9612468-2026-08139
• Device Sequence Number: 18733659
• Product Code: DZE
• UDI-Device Identifier: 07392532276804
• UDI-Public: 07392532276804
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 09/11/2026

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: 68011107
• Device Lot Number: 533760
• 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: 08/13/2026
• Initial Report FDA Received Date: 09/11/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown