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
Additional Manufacturer Narrative
The batch number could be verified.Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.  the removal of a dental implant during surgery without the replacement of another dental implant is a known inherent risk of the procedure due to either lack of primary stability of the implant (patienor procedure related).It may also include the removal of an implant after osseointegration due to either the clinician's or patient¿s decision.The manufacturer¿s trend analysis confirms that usually procedural errors and/or patient's condition contribute to the event.
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: 12722343
• Report Number: 0009613348-2021-82921
• Device Sequence Number: 11726413
• Product Code: DZE
• UDI-Device Identifier: 07630031707253
• UDI-Public: 07630031707253
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K121131
• 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: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2016
• 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