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

Catalog Number MG-STN3

Device Problem Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Organ Dehiscence (2502)

Event Type  Injury  

Event Description

When the guide was removed after a guided surgery, it turned out that the implant in regio 18 was placed to much to buccal side, the bone was fenestrated.The implant had to be removed.

Manufacturer Narrative

Because a serious injury resulted, this event is reportable per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

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

• Brand Name: MGUIDE
• 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: 12803715
• MDR Text Key: 280699426
• Report Number: 3007362683-2021-00010
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MG-STN3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 10/23/2021
• Supplement Dates FDA Received: 01/21/2022
• 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