MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL, Ø 3.3MM NC, SLACT. 12MM, RXD, GUIDED; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	021.2212G
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2016 in ada 22.On (b)(6) 2025, fracture of the implant was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications 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) 2016 in the patient's mouth.On (b)(6) 2025, fracture of the implant was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.

• Brand Name: BL, Ø 3.3MM NC, SLACT. 12MM, RXD, GUIDED
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 22218000
• Report Number: 0001222315-2025-001022
• Device Sequence Number: 8157956
• Product Code: DZE
• UDI-Device Identifier: 07630031706430
• UDI-Public: 07630031706430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025
• Report Date (Section F): 03/19/2025

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: 06/03/2020
• Device Catalogue Number: 021.2212G
• Device Lot Number: JV681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2025
• Device Age: 116 MO
• Event Location: Other
• Date Report to Manufacturer: 03/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 06/17/2025
• 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: 82 YR
• Patient Sex: Male