MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S-IMPLANT Ø 3.3MM, RN, SLACTIVE, 12MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	033.133S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2014 in ada 22.Details of surgery: immediate extraction site.On (b)(6) 2025, fracture of the implant was verified.Patient presented with poor oral hygiene.The device was forwarded to the manufacturer.At the event the patient experienced: peri-implantitis, pain, swelling and bleeding.No further patient complications were reported.

• Brand Name: S-IMPLANT Ø 3.3MM, RN, SLACTIVE, 12MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 22483216
• Report Number: 0001222315-2025-001943
• Device Sequence Number: 15620441
• Product Code: DZE
• UDI-Device Identifier: 07630031714787
• UDI-Public: 07630031714787
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/11/2025
• Report Date (Section F): 06/17/2025

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 Expiration Date: 02/28/2017
• Device Catalogue Number: 033.133S
• Device Lot Number: CX346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2025
• Device Age: 159 MO
• Event Location: Other
• Date Report to Manufacturer: 06/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male