MAUDE Adverse Event Report: INSTITUT STRAUMANN AG CIM 4.1MM RD, ZLA 14MM, AH5.5MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT

Model Number	Ceramic TL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 6.Details of surgery: ridge augmentation.On (b)(6) 2020, loss of osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: pain, mobility and inflammation.No further patient complications were reported.

• Brand Name: CIM 4.1MM RD, ZLA 14MM, AH5.5MM, ZRO2
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; CH 04002
• MDR Report Key: 10735189
• Report Number: 0001222315-2020-12802
• Device Sequence Number: 1926494
• Product Code: DZE
• UDI-Device Identifier: 07630031714015
• UDI-Public: 07630031714015
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K151328
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/26/2020
• Report Date (Section F): 09/30/2020

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: 03/22/2024
• Device Model Number: Ceramic TL
• Device Catalogue Number: 031.034S
• Device Lot Number: VW446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2020
• Device Age: 16 MO
• Event Location: Other
• Date Report to Manufacturer: 09/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR