MAUDE Adverse Event Report: Institut Straumann AG BL, ? 4.8mm RC, SLA? 8mm, Ti, Loxim; Endosseous Dental Implant

Catalog Number	021.6608
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury

• Brand Name: BL, ? 4.8mm RC, SLA? 8mm, Ti, Loxim
• 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: 50920899
• Report Number: 0009613348-2026-015158
• Device Sequence Number: 14903876
• Product Code: DZE
• UDI-Device Identifier: 07630031707390
• UDI-Public: 07630031707390
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062129
• 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,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 021.6608
• Device Lot Number: GCLH1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• 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: 09/28/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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: 57 YR
• Patient Sex: Male