MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP, Ø 3.3 MM NN, SLACTIVE 12 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	033.953S
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2009 in ada 25.Details of surgery: ridge augmentation.On (b)(6) 2023, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: bleeding and inflammation.No further patient complications were reported.

• Brand Name: SP, Ø 3.3 MM NN, SLACTIVE 12 MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 17845183
• Report Number: 0001222315-2023-023788
• Device Sequence Number: 12560926
• Product Code: DZE
• UDI-Device Identifier: 07630031716606
• UDI-Public: 07630031716606
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 09/29/2023
• Report Date (Section F): 09/05/2023

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: 04/30/2013
• Device Catalogue Number: 033.953S
• Device Lot Number: K2503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/29/2023
• Device Age: 183 MO
• Event Location: Other
• Date Report to Manufacturer: 09/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2023
• 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: 72 YR
• Patient Sex: Female