MAUDE Adverse Event Report: INSTITUT STRAUMANN AG CI Ø4.1MM RD, ZLA 14MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	032.003S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024 in ada 30.On (b)(6) 2024, non-osseointegration was verified.No product was returned to the manufacturer.There were no reported patient injuries or complications.
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) 2024 in ada 30.On (b)(6) 2024, non-osseointegration was verified.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.

• Brand Name: CI Ø4.1MM RD, ZLA 14MM, ZRO2
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 18971267
• Report Number: 0001222315-2024-000769
• Device Sequence Number: 20475769
• Product Code: DZE
• UDI-Device Identifier: 07630031714305
• UDI-Public: 07630031714305
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/17/2024
• Report Date (Section F): 02/29/2024

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 Catalogue Number: 032.003S
• Device Lot Number: KLL78
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2024
• Device Age: 20 MO
• Event Location: Other
• Date Report to Manufacturer: 02/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/17/2024
• 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 Sex: Male