MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP IMPL., Ø 4.8MM RN, SLACTIVE 14MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLActive Titanium TL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Fibrosis (3167)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2015 in ada 5.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2023, loss of osseointegration was verified.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.

• Brand Name: SP IMPL., Ø 4.8MM RN, SLACTIVE 14MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 16834804
• Report Number: 0001222315-2023-010199
• Device Sequence Number: 12484961
• Product Code: DZE
• UDI-Device Identifier: 07630031714978
• UDI-Public: 07630031714978
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 04/28/2023
• Report Date (Section F): 04/04/2023

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: 02/29/2012
• Device Model Number: SLActive Titanium TL
• Device Catalogue Number: 033.254S
• Device Lot Number: E8816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2023
• Device Age: 193 MO
• Event Location: Other
• Date Report to Manufacturer: 04/04/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2023
• 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: 77 YR
• Patient Sex: Male