MAUDE Adverse Event Report: Institut Straumann AG BLC ?4.5mm WB, SLA 8mm RXD; Endosseous Dental Implant

Catalog Number	035.8408S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Abscess (1690); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Fibrosis (3167); Swelling/ Edema (4577)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted 2026 (b)(6) in ada 18.On 2026 (b)(6), non-osseointegration was verified.Patient presented with fair oral hygiene.The device was forwarded to the manufacturer.At the event the patient experienced: infection, pain, mobility, swelling, bleeding and abscess.No further patient complications were reported.

• Brand Name: BLC ?4.5mm WB, SLA 8mm RXD
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Institut Straumann AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 50737726
• Report Number: 0001222315-2026-002800
• Device Sequence Number: 10599489
• Product Code: DZE
• UDI-Device Identifier: 07630031764355
• UDI-Public: 07630031764355
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/11/2026
• Report Date (Section F): 09/11/2026

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: 035.8408S
• Device Lot Number: ZVTV6
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2026
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 08/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2026
• 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: 67 YR
• Patient Sex: Male