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	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Fibrosis (3167); Hyperresponsive to stimuli (4538); Swelling/ Edema (4577)
Date of Event	08/09/2021
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) 2021, loss of osseointegration was verified.Patient presented with bone type iii and previous bone augmentation.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 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 ; SZ 04002
• MDR Report Key: 12563387
• Report Number: 0001222315-2021-16362
• Device Sequence Number: 1479206
• Product Code: DZE
• UDI-Device Identifier: 07630031714015
• UDI-Public: 07630031714015
• 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: 2020
• 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): 10/01/2021
• Report Date (Section F): 09/07/2021

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: 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: 09/07/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2021
• Device Age: 29 MO
• Event Location: Other
• Date Report to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2021
• 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