MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL,Ø4.1MM RC, SLACT.12MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	021.4312G
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Abscess (1690); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fibrosis (3167); Swelling/ Edema (4577)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2023 in ada 28.Details of surgery: ridge augmentation and immediate extraction site.On 2023-05-22, non-osseointegration was verified.Patient presented with fair oral hygiene and inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: infection, peri-implantitis, pain, mobility, swelling, bleeding, abscess and inflammation.No further patient complications were reported.

• Brand Name: BL,Ø4.1MM RC, SLACT.12MM,ROXOLID,GUIDED
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 18205140
• Report Number: 0001222315-2023-029168
• Device Sequence Number: 6414767
• Product Code: DZE
• UDI-Device Identifier: 07630031706881
• UDI-Public: 07630031706881
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/24/2023
• Report Date (Section F): 10/31/2023

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 Catalogue Number: 021.4312G
• Device Lot Number: MJF36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/24/2023
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 10/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2023
• 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: 66 YR
• Patient Sex: Male