MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS IMPLANTMED SI-1023 INCL. ATTACHMENT WI-75 LED G

Model Number SI-1023

Device Problem Use of Device Problem (1670)

Patient Problems Tactile Disorders (4419); Paresthesia (4421)

Event Date 03/21/2022

Event Type  Injury  

Event Description

Implant bed was already prepared; in the course of inserting a camlog (progressive line 3.8mm), the automatic torque was activated and the unit stopped without error.The operator used the foot switch to activate counterclockwise rotation (signal sounds before start) and turned the implant back approx.2 revolutions; user wanted to return to clockwise rotation and inadvertently pressed the wrong program button, which changed to the wrong program.The warning tone was not perceived accoustically by the user.The control look at the display was also not carried out.This resulted in a too fast insertion of the implant which led to a subcrestal insertion (4mm too deep).

Manufacturer Narrative

After a telephone conversation with the doctor, it was determined that it was purely user error.The device works perfectly.Therefore, the device can remain with the user and an investigation was not necessary.

• Brand Name: IMPLANTMED SI-1023 INCL. ATTACHMENT WI-75 LED G
• Type of Device: IMPLANTMED
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS; ignaz-glaser strasse 53; buermoos, austria 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BUERMOOS; ignaz-glaser strasse 53; buermoos, austria 5111 ; AU 5111
• Manufacturer Contact: gerhard mag. dr. weidler ; ignaz-glaser strasse 53; buermoos, austria 5111 ; AU 5111
• MDR Report Key: 14081081
• MDR Text Key: 289060628
• Report Number: 9681479-2022-00001
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2022

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
• Device Operator: Health Professional
• Device Model Number: SI-1023
• Device Catalogue Number: 3028800016568
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 41 YR
• Patient Sex: Female