MAUDE Adverse Event Report: Dentsply Implants Manufacturing GmbH PrimeTaper EV Ø4.8 x 11mm OS; implant, endosseous, root-form

Catalog Number	68011106
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss.Also, it was reported that they had unspecified infection and osteolysis.
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.

• Brand Name: PrimeTaper EV Ø4.8 x 11mm OS
• Common Device Name: implant, endosseous, root-form
• Manufacturer (Section D): Dentsply Implants Manufacturing GmbH; rodenbacher chaussee 4; 63457 hanau; hessen ; GM
• Manufacturer (Section G): Dentsply IH AB; aminogatan 1; s-431 21 molndal vastra gotala; SW
• Manufacturer Contact: dan eager ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 1(717)845-7511
• MDR Report Key: 50458276
• Report Number: 3013111692-2026-39351
• Device Sequence Number: 16018282
• Product Code: DZE
• UDI-Device Identifier: 07392532276798
• UDI-Public: 07392532276798
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 68011106
• Device Lot Number: 519431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown