MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BLX Ø5.5 WB, SLA® 14MM, RXD; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLA Roxolid BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports that the day the implant was placed in ada 19, failure occurred upon insertion.Details of surgery: primary stability not achieved and immediate extraction site.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.

• Brand Name: BLX Ø5.5 WB, SLA® 14MM, RXD
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 15219414
• Report Number: 0001222315-2022-16918
• Device Sequence Number: 5787385
• Product Code: DZE
• UDI-Device Identifier: 07630031755384
• UDI-Public: 07630031755384
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/12/2022
• Report Date (Section F): 07/19/2022

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: 01/11/2026
• Device Model Number: SLA Roxolid BL
• Device Catalogue Number: 061.8514
• Device Lot Number: EPN57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2022
• Device Age: 17 MO
• Event Location: Other
• Date Report to Manufacturer: 07/19/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2022
• 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: 44 YR
• Patient Sex: Male