MAUDE Adverse Event Report: Institut Straumann AG SP ? 4.1mm RN, SLActive? 12mm, TiZr, NTP; Endosseous Dental Implant

Catalog Number	033.563S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury

• Brand Name: SP ? 4.1mm RN, SLActive? 12mm, TiZr, NTP
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Institut Straumann AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer (Section G): Institut Straumann AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; +1(978)747-2509
• MDR Report Key: 50739028
• Report Number: 0009613348-2026-014231
• Device Sequence Number: 10591624
• Product Code: DZE
• UDI-Device Identifier: 07630031715982
• UDI-Public: 07630031715982
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122855
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/11/2026

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: 033.563S
• Device Lot Number: VKWH8
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2025
• 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