MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S-IMPLANT Ø 4.8MM WN, SLACTIVE 12MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	033.633S
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2009 in ada 14.Details of surgery: primary stability not achieved and implant surface not completely covered with bone.On (b)(6) 2024, loss of osseointegration was verified.Patient presented with bone type iii, bruxism and inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.

• Brand Name: S-IMPLANT Ø 4.8MM WN, SLACTIVE 12MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 20159658
• Report Number: 0001222315-2024-002378
• Device Sequence Number: 7235850
• Product Code: DZE
• UDI-Device Identifier: 07630031716354
• UDI-Public: 07630031716354
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 09/06/2024
• Report Date (Section F): 08/13/2024

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 Expiration Date: 04/30/2009
• Device Catalogue Number: 033.633S
• Device Lot Number: A8422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2024
• Device Age: 240 MO
• Event Location: Other
• Date Report to Manufacturer: 08/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• 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: 55 YR
• Patient Sex: Male