MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. MGUIDE CASE, 3 SITES; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number MG-STN3

Device Problems Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.

Event Description

It was reported that a patient experienced a dental implant loss.

Event Description

Treatment was stopped because of mguide did not fit in patient's mouth.

Manufacturer Narrative

Investigation summary: we received only the guide.No model.Fit issue cannot be investigated.Dhr was conducted, no issues found.Model and guide were sent to us as stl - files by the customer (pro - user).Based on customers data (customer designed the guide).No issues found.Model for the remake differs from original model.Based on this customers data, customer redesigned the guide.Please disregard the initial report - this is not a dental implant loss.This was mistakenly entered.Correcting describe event or problem from (b5) "it was reported that a patient experienced a dental implant loss." to corrected statement of : treatment was stopped because of mguide did not fit in patient's mouth.This is to correct and remove the codes that were initially reported - removing codes for: medical device problem code - 1158, type of investigation code - 4112.The corrected and/or additional codes for this event are: medical device problem code - 2993, type of investigation code - 10 + 3331, investigation findings code - 213, investigation conclusions code - 67.

• Brand Name: MGUIDE CASE, 3 SITES
• 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 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 14752453
• MDR Text Key: 294384236
• Report Number: 3007362683-2022-00024
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MG-STN3
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/13/2022
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention