MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SIMPLANT GUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 37502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

Because a serious injury resulted, this complaint is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.We are waiting to receive the products back for complete investigating.So far, the preliminary investigation could only be performed on the digital design files.The digital design of the product does not show any abnormalities.This event is reportable per 21 cfr part 803.Evaluation results will be submitted as they become available.

Event Description

A clinician used a simplant safe guide to create the osteotomy for implant sites 45 and 46 in combination with the astra tech surgery kit.The customer had an incident with the patient where he installed an astra implant in the lower jaw with an open sleeve (position 46).Unfortunately, the mandibular nerve was penetrated during the surgery and the patient had to go to the hospital, the patient lost the sensation in lower part of face.

Manufacturer Narrative

The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: SIMPLANT GUIDE
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer (Section G): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 13175329
• MDR Text Key: 283388477
• Report Number: 3007362683-2021-00012
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1