MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TLX S Ø4.5 RT, SLACTIVE® 12MM, RXD; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	035.1512S
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fibrosis (3167); Hyperresponsive to stimuli (4538)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2023 in ada 4.On (b)(6) 2023, loss of osseointegration was verified.Patient presented with previous bone augmentation.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 Ø4.5 RT, SLACTIVE® 12MM, RXD
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 19022276
• Report Number: 0001222315-2024-000828
• Device Sequence Number: 14423044
• Product Code: DZE
• UDI-Device Identifier: 07630031751331
• UDI-Public: 07630031751331
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/02/2024
• Report Date (Section F): 03/08/2024

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: 035.1512S
• Device Lot Number: NRK82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2024
• Device Age: 13 MO
• Event Location: Other
• Date Report to Manufacturer: 03/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• 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: 37 YR
• Patient Sex: Male