MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL, Ø 3.3 MM NC, SLACTIVE 14 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	021.2114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2011 in ada 6.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2024, fracture of the implant was verified.The device was forwarded to the manufacturer.At the event the patient experienced: bleeding.No further patient complications were reported.
Additional Manufacturer Narrative
Non-fatal serious injury or device malfunction stored due to covid 19 pandemic in accordance with fda guidance "postmarketing adverse event reporting for medical products and dietary supplements during a pandemic" published may 2020.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2011 in ada 6.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2024, fracture of the implant was verified.The device was forwarded to the manufacturer.At the event the patient experienced: bleeding.No further patient complications were reported.

• Brand Name: BL, Ø 3.3 MM NC, SLACTIVE 14 MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 20547947
• Report Number: 0001222315-2024-002879
• Device Sequence Number: 7532479
• Product Code: DZE
• UDI-Device Identifier: 07630031706379
• UDI-Public: 07630031706379
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025
• Report Date (Section F): 10/03/2024

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: 12/31/2014
• Device Catalogue Number: 021.2114
• Device Lot Number: X4249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2025
• Device Age: 176 MO
• Event Location: Other
• Date Report to Manufacturer: 10/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 06/18/2025
• 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: 69 YR
• Patient Sex: Male