MAUDE Adverse Event Report: BL,Ø4.8MM RC, SLACT.8MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLActive Roxolid BL
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports that the day the implant was placed in ada 3, failure occurred upon insertion.Details of surgery: primary stability not achieved, implant surface not completely covered with bone and sinus augmentation.Patient presented with bone type iv and 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: BL,Ø4.8MM RC, SLACT.8MM,ROXOLID,GUIDED
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• MDR Report Key: 12721546
• Report Number: 0001222315-2021-18564
• Device Sequence Number: 15802723
• Product Code: DZE
• UDI-Device Identifier: 07630031707253
• UDI-Public: 07630031707253
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/29/2021
• Report Date (Section F): 10/05/2021

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: 09/04/2021
• Device Model Number: SLActive Roxolid BL
• Device Catalogue Number: 021.6308G
• Device Lot Number: MC356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/29/2021
• Device Age: 59 MO
• Event Location: Other
• Date Report to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2021
• 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