MAUDE Adverse Event Report: Institut Straumann AG BLX ?3.5 RB, SLActive? 10mm, RXD; Endosseous Dental Implant

Catalog Number	061.3310
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury

• Brand Name: BLX ?3.5 RB, SLActive? 10mm, RXD
• 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: 50758292
• Report Number: 0009613348-2026-014243
• Device Sequence Number: 15793134
• Product Code: DZE
• UDI-Device Identifier: 07630031743282
• UDI-Public: 07630031743282
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K191256
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 061.3310
• Device Lot Number: MFH01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2022
• 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 Age: 74 YR
• Patient Sex: Male