MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP, Ø 4.8MM RN, SLACT. 8MM, GUIDED; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLActive Titanium TL
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Fistula (1862); Inflammation (1932); Fibrosis (3167)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2021 in ada 19.On (b)(6) 2021, non-osseointegration was verified.Patient presented with bone type iii and inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: mobility, fistula and inflammation.No further patient complications were reported.

• Brand Name: SP, Ø 4.8MM RN, SLACT. 8MM, GUIDED
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 13398284
• Report Number: 0001222315-2022-01828
• Device Sequence Number: 4025976
• Product Code: DZE
• UDI-Device Identifier: 07630031714916
• UDI-Public: 07630031714916
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/31/2022
• Report Date (Section F): 01/06/2022

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: 11/30/2014
• Device Model Number: SLActive Titanium TL
• Device Catalogue Number: 033.251G
• Device Lot Number: X1416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2022
• Device Age: 145 MO
• Event Location: Other
• Date Report to Manufacturer: 01/06/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2022
• 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: 67 YR
• Patient Sex: Male