MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TLC SP, Ø4.5MM RT, SLA 8MM RXD; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	035.6508S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Sinus Perforation (2277); Fibrosis (3167)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2025 in ada 3.Details of surgery: primary stability not achieved, implant surface not completely covered with bone, sinus perforation and sinus augmentation.On (b)(6) 2025, non-osseointegration was verified.Patient presented with bone type iv, inadequate bone quality/quantity and previous bone augmentation.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.

• Brand Name: TLC SP, Ø4.5MM RT, SLA 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: 23281198
• Report Number: 0001222315-2025-002875
• Device Sequence Number: 18333501
• Product Code: DZE
• UDI-Device Identifier: 07630031765864
• UDI-Public: 07630031765864
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 10/13/2025
• Report Date (Section F): 09/18/2025

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: 035.6508S
• Device Lot Number: LFFT8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/13/2025
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 09/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• 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: 66 YR
• Patient Sex: Male