MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL,Ø4.1MM RC, SLACT.10MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	021.4310G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports that the day the implant was placed in ada 21, failure occurred upon insertion.Details of surgery: primary stability not achieved, implant surface not completely covered with bone, ridge augmentation and immediate extraction site.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: infection, pain and bleeding.No further patient complications were reported.

• Brand Name: BL,Ø4.1MM RC, SLACT.10MM,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: 22257283
• Report Number: 0001222315-2025-001390
• Device Sequence Number: 7794484
• Product Code: DZE
• UDI-Device Identifier: 07630031706867
• UDI-Public: 07630031706867
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/23/2025
• Report Date (Section F): 04/29/2025

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: 11/19/2025
• Device Catalogue Number: 021.4310G
• Device Lot Number: CZK81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2025
• Device Age: 53 MO
• Event Location: Other
• Date Report to Manufacturer: 04/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2025
• 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: 77 YR
• Patient Sex: Male