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

Model Number	SLActive Titanium TL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fibrosis (3167); Swelling/ Edema (4577)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2013 in ada 14.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2023, loss of osseointegration was verified.Patient presented with bone type iv.The device was forwarded to the manufacturer.At the event the patient experienced: peri-implantitis, pain, mobility, swelling, bleeding, abscess, fistula and inflammation.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: 17200672
• Report Number: 0001222315-2023-015849
• Device Sequence Number: 6667133
• Product Code: DZE
• UDI-Device Identifier: 07630031716354
• UDI-Public: 07630031716354
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 06/26/2023
• Report Date (Section F): 05/31/2023

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: 03/31/2018
• Device Model Number: SLActive Titanium TL
• Device Catalogue Number: 033.633S
• Device Lot Number: FJ374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2023
• Device Age: 120 MO
• Event Location: Other
• Date Report to Manufacturer: 05/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2023
• 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: 73 YR
• Patient Sex: Male