MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TLX S Ø6.5 WT, SLACTIVE® 6MM, RXD; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	035.1806S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Fibrosis (3167); Hyperresponsive to stimuli (4538)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted on (b)(6) 2024 in ada 30.Details of surgery: primary stability not achieved and implant surface not completely covered with bone.On (b)(6) 2024, non-osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: mobility and increased sensitivity.No further patient complications were reported.

• Brand Name: TLX S Ø6.5 WT, SLACTIVE® 6MM, RXD
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 21037297
• Report Number: 0001222315-2024-003489
• Device Sequence Number: 8538824
• Product Code: DZE
• UDI-Device Identifier: 07630031752055
• UDI-Public: 07630031752055
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/30/2024
• Report Date (Section F): 12/02/2024

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: 035.1806S
• Device Lot Number: JVG02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/30/2024
• Device Age: 23 MO
• Event Location: Other
• Date Report to Manufacturer: 12/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• 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: 56 YR
• Patient Sex: Male