MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE - 1 IMPLANT; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Positioning Failure (1158)

Patient Problems Failure of Implant (1924); Laceration(s) (1946)

Event Date 07/22/2022

Event Type  Injury  

Event Description

In this event it is reported that surgiguide had placement issue; the implant exited through the bone and surgery was unsuccessful.The patient was supplemented with material in the place of the selected bone.The patient is fine and we will continue with the new template in august / september.

Manufacturer Narrative

This event is reportable per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Fda coding was missed in the initial report.Adding additional health effect- clinical code 1946.This is a follow up report to add this additional code.Fda coding was missed in the initial report.Adding additional type of investigation codes 10 and 3331.This is a follow up report to add this additional code.Fda coding was missed in the initial report.Adding additional investigation findings code 114.This is a follow up report to add this additional code.Fda coding was missed in the initial report.Adding additional investigation conclusions code 4310.This is a follow up report to add this additional code.

• Brand Name: SURGIGUIDE - 1 IMPLANT
• 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: 15164227
• MDR Text Key: 297237836
• Report Number: 3007362683-2022-00026
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNIQUE REFERENCE PER ORDER (CU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/28/2022
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention