MAUDE Adverse Event Report: CIM Ø3.3MM ND, ZLA 14MM, AH4MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT

Model Number	Ceramic TL
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2021 in ada 10.Details of surgery: implant surface not completely covered with bone, ridge augmentation and immediate extraction site.On (b)(6) 2021, non-osseointegration was verified.Patient presented with bone type iii, fair oral hygiene and bruxism.The device was forwarded to the manufacturer.At the event the patient experienced: infection and pain.No further patient complications were reported.

• Brand Name: CIM Ø3.3MM ND, ZLA 14MM, AH4MM, ZRO2
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• MDR Report Key: 12606825
• Report Number: 0001222315-2021-16915
• Device Sequence Number: 1414722
• Product Code: DZE
• UDI-Device Identifier: 07630031713810
• UDI-Public: 07630031713810
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/11/2021
• Report Date (Section F): 09/15/2021

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: 01/24/2024
• Device Model Number: Ceramic TL
• Device Catalogue Number: 031.004S
• Device Lot Number: TW598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2021
• Device Age: 31 MO
• Event Location: Other
• Date Report to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2021
• 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: 57 YR