MAUDE Adverse Event Report: DENTSPLY IH INC. SURGIGUIDE - 1 IMPLANT; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The actual guide was not received for investigation, but the digital planning was evaluated without having found any issues.Trend is tracked and monitored.

Event Description

In this event it is reported that a surgiguide -that was used for an implant surgery - customer tried placing implant at implant site #14 as designed in azento planning.However, when placing the implant on the day of surgery, the customer felt that #14 was getting too close to adjacent tooth roots.Customer took a radiograph to confirm (will be sending radiograph to us) and removed the implant.Customer then grafted the area with bone grafting and the patient is now ready to have another implant placed in this site.The patient was fine and no follow up treatment was necessary due to the implant removal immediately after placement.Additional information about the adjacent tooth root: it was tooth # 15.

• Brand Name: SURGIGUIDE - 1 IMPLANT
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IH INC.; 590 lincoln street; north waltham MA 02451
• Manufacturer (Section G): DENTSPLY IH INC.; 590 lincoln street; north waltham MA 02451
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18864436
• MDR Text Key: 337184867
• Report Number: 1222802-2024-00004
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/08/2024

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?: No
• 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: 02/13/2024
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 26340 ASTRATECH IMPL EV 4.8S 6MM OS.