MAUDE Adverse Event Report: INSTITUT STRAUMANN AG CI Ø4.1MM RD, ZLA 10MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	032.001S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Fibrosis (3167)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025 in ada 30.On (b)(6) 2026, non-osseointegration was verified.No product was returned to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025 in ada 30.On (b)(6) 2026, non-osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.
Additional Manufacturer Narrative
Non-fatal serious injury or device malfunction stored due to covid 19 pandemic in accordance with fda guidance "postmarketing adverse event reporting for medical products and dietary supplements during a pandemic" published may 2020.

• Brand Name: CI Ø4.1MM RD, ZLA 10MM, ZRO2
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 24608828
• Report Number: 0001222315-2026-000786
• Device Sequence Number: 21290514
• Product Code: DZE
• UDI-Device Identifier: 07630031714282
• UDI-Public: 07630031714282
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K180477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026
• Report Date (Section F): 02/19/2026

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: 032.001S
• Device Lot Number: TWJ19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2026
• Device Age: 34 MO
• Event Location: Other
• Date Report to Manufacturer: 02/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/13/2026
• 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 Age: 19 YR
• Patient Sex: Male