MAUDE Adverse Event Report: INSTITUT STRAUMANN AG CIM Ø4.1MM RD, ZLA 12MM, AH4MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	031.023S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Fibrosis (3167); Hyperresponsive to stimuli (4538); Swelling/ Edema (4577)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2023 in ada 30.Details of surgery: implant surface not completely covered with bone, ridge augmentation and immediate extraction site.On 2024-03-13, non-osseointegration was verified.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: pain, mobility, swelling, bleeding, increased sensitivity and inflammation.No further patient complications were reported.

• Brand Name: CIM Ø4.1MM RD, ZLA 12MM, 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: 19136483
• Report Number: 0001222315-2024-001003
• Device Sequence Number: 4722261
• Product Code: DZE
• UDI-Device Identifier: 07630031713919
• UDI-Public: 07630031713919
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/18/2024
• Report Date (Section F): 03/25/2024

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: 031.023S
• Device Lot Number: GCN62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2024
• Device Age: 25 MO
• Event Location: Other
• Date Report to Manufacturer: 03/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• 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: 44 YR
• Patient Sex: Male