MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP, Ø4.8MM RN, SLA 14MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	043.254S
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Fibrosis (3167)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2011 in ada 14.On (b)(6) 2023, loss of osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: infection, peri-implantitis, mobility, bleeding and fistula.No further patient complications were reported.

• Brand Name: SP, Ø4.8MM RN, SLA 14MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 17853335
• Report Number: 0001222315-2023-024134
• Device Sequence Number: 19680577
• Product Code: DZE
• UDI-Device Identifier: 07630031701022
• UDI-Public: 07630031701022
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/02/2023
• Report Date (Section F): 09/06/2023

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: 01/31/2012
• Device Catalogue Number: 043.254S
• Device Lot Number: E6972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2023
• Device Age: 199 MO
• Event Location: Other
• Date Report to Manufacturer: 09/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2023
• 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: 52 YR
• Patient Sex: Male