MAUDE Adverse Event Report: DENTSPLY Implants (a Division of DENTSPLY IH AB) PrimeTaper EV Ø5.4 x 11mm OS; Implant, Endosseous, Root-Form

Catalog Number	68011113
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a scan body issue occurred.The customer reported being unable to fully seat the atlantis scan body due to interference at the implant-abutment interface.The implant was placed and buried, then uncovered three months later for placement of a healing abutment.Reverse torque testing demonstrated implant stability at 30 ncm, and the patient reported no pain.Multiple attempts were made to seat the scan body; however, it could not be fully seated.Periapical radiographs were obtained, and the patient returned for a follow-up appointment with the sales representative.Additional intraoral photographs and periapical radiographs were taken.Based on the clinical and radiographic evaluation, a defect at the base of the implant was identified, preventing the scan body from fully seating.The customer was advised to remove the implant, perform bone grafting, and replace the implant.
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our experience in the investigation of similar complaints.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.

• Brand Name: PrimeTaper EV Ø5.4 x 11mm 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 ; +1(717)845-7511
• MDR Report Key: 50089560
• Report Number: 9612468-2026-03897
• Device Sequence Number: 10479374
• Product Code: DZE
• UDI-Device Identifier: 07392532276866
• UDI-Public: 07392532276866
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 68011113
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/30/2026
• 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: 25274.
• Patient Sex: Unknown