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

Catalog Number 37501

Device Problems Structural Problem (2506); Malposition of Device (2616)

Patient Problems Numbness (2415); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This failing treatment is due to a suboptimal pre-operative plan created in the simplant software but approved by the customer.Because a serious injury resulted, this event is reportable per 21cfr part 803.Evaluation of the guide model showed the tooth on position 35 is a removable crown.The doctor removed the crown during the ct scan but kept it when he took an impression for the stone model.If the crown was in the patient's mouth during the surgery, it can affect the fit and stability of the guide.

Event Description

It was reported that a patient received a dental implant with the aid of a simplant safe guide.The x-ray after surgery shows that the inserted implant touched the neighboring tooth root.The implant was lost three days after insertion due to lack of stability.This loss exposed the neighboring tooth and bone augmentation was attempted, but not successful.Currently, tooth is functional, but the doctor is unsure if the tooth can be preserved.The patient is not suffering from pain.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• 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: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6785565
• MDR Text Key: 82402639
• Report Number: 3007362683-2017-00001
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention