MAUDE Adverse Event Report: MIS Implants Technologies Ltd. OsseoSpeed EV 4.2 C - 11 mm; implant, endosseous, root-form

Catalog Number	MD-TBC15
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: OsseoSpeed EV 4.2 C - 11 mm
• Common Device Name: implant, endosseous, root-form
• Manufacturer (Section D): MIS Implants Technologies Ltd.; 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: 50938392
• Report Number: 3013111692-2026-42785
• Device Sequence Number: 13450870
• Product Code: DZE
• UDI-Device Identifier: 07290109012490
• UDI-Public: 07290109012490
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: UNK
• 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): 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: MD-TBC15
• 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: 09/29/2026
• 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: Other; Required Intervention
• Patient Sex: Unknown