MAUDE Adverse Event Report: Dentsply Implants Manufacturing GmbH OsseoSpeed EV 5.4 S - 9 mm; implant, endosseous, root-form

Catalog Number	25253
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury

• Brand Name: OsseoSpeed EV 5.4 S - 9 mm
• Common Device Name: implant, endosseous, root-form
• Manufacturer (Section D): Dentsply Implants Manufacturing GmbH; fabrikstrasse 31; bensheim ; GM
• Manufacturer (Section G): Dentsply Implants Manufacturing GmbH; fabrikstrasse 31; bensheim ; GM
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; suite 60 w; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50941567
• Report Number: 3013111692-2026-42805
• Device Sequence Number: 13443184
• Product Code: DZE
• UDI-Device Identifier: 07392532132889
• UDI-Public: 07392532132889
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 25253
• Device Lot Number: 438685
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown