MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE - 2 IMPLANTS; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 37502

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 03/09/2022

Event Type  Injury  

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.

Manufacturer Narrative

Fda coding was missed in the initial report.Adding additional type of investigation 10 + 3331.Adding additional investigation finding 213.Adding additional investigation conclusions code 4310.This is a follow up report to add this additional code.

• Brand Name: SURGIGUIDE - 2 IMPLANTS
• 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: 15051365
• MDR Text Key: 296129671
• Report Number: 3007362683-2022-00025
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 37502
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/04/2022
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 2 X 31010428 (LOT 464230 UND 457407)
• Patient Outcome(s): Required Intervention