MAUDE Adverse Event Report: INSTITUT STRAUMANN AG CIM Ø3.3MM ND, ZLA 8MM, AH4MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	031.001S
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2023 in ada 13.On (b)(6) 2024, loss of osseointegration was verified.Patient presented with previous bone augmentation.No product was returned to the manufacturer.At the event the patient experienced: pain.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) 2023 in ada 13.On (b)(6) 2024, loss of osseointegration was verified.Patient presented with previous bone augmentation.The device was forwarded to the manufacturer.At the event the patient experienced: pain.No further patient complications were reported.

• Brand Name: CIM Ø3.3MM ND, ZLA 8MM, AH4MM, ZRO2
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 19539661
• Report Number: 0001222315-2024-001605
• Device Sequence Number: 6333940
• Product Code: DZE
• UDI-Device Identifier: 07630031713780
• UDI-Public: 07630031713780
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/09/2024
• Report Date (Section F): 05/21/2024

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: 031.001S
• Device Lot Number: JCM56
• 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: 08/09/2024
• Device Age: 25 MO
• Event Location: Other
• Date Report to Manufacturer: 05/21/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/09/2024
• 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 Age: 36 YR
• Patient Sex: Male