MAUDE Adverse Event Report: Institut Straumann AG SP, ? 4.8 mm, RN, SLA 10.0 mm; Endosseous Dental Implant

Catalog Number	043.252S
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted 2013-(b)(6) in ada 4.Details of surgery: implant surface not completely covered with bone.On 2026-(b)(6), loss of osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.

• Brand Name: SP, ? 4.8 mm, RN, SLA 10.0 mm
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Institut Straumann AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 50039680
• Report Number: 0001222315-2026-002256
• Device Sequence Number: 18619059
• Product Code: DZE
• UDI-Device Identifier: 07630031701008
• UDI-Public: 07630031701008
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 07/27/2026
• Report Date (Section F): 07/27/2026

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 Expiration Date: 05/31/2017
• Device Catalogue Number: 043.252S
• Device Lot Number: EF856
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2026
• Device Age: 169 MO
• Event Location: Other
• Date Report to Manufacturer: 07/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• 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: 73 YR
• Patient Sex: Male