MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TLX S Ø5.5 WT, SLACTIVE® 8MM, RXD; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	035.1708S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024 in ada 31.On (b)(6) 2025, non-osseointegration was verified.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: pain.No further patient complications were reported.

• Brand Name: TLX S Ø5.5 WT, SLACTIVE® 8MM, RXD
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 22257809
• Report Number: 0001222315-2025-001438
• Device Sequence Number: 7850121
• Product Code: DZE
• UDI-Device Identifier: 07630031752024
• UDI-Public: 07630031752024
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/27/2025
• Report Date (Section F): 04/04/2025

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 Catalogue Number: 035.1708S
• Device Lot Number: WNA43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2025
• Device Age: 19 MO
• Event Location: Other
• Date Report to Manufacturer: 04/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2025
• 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 Age: 53 YR
• Patient Sex: Male