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

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Positioning Failure (1158)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

In this event it is reported that surgiguide - 1 implant , for the surgical guide for tooth #19, the guide had a poor fit.Doctor went ahead and tried to go through the progression of implant drills.When placing the implant, it had no torque and spun in the osteotomy site.Likely due to the osteotomies not being in the exact same site due to poor fit.Doctor aborted the surgery since he felt like the osteotomy was too wide, and grafted the site with allogenic bone graft.The customer did not check the fit before the patient was sedated.He cutted the guide for a good fit: to check if it would fit better the natural dentition better.Additional information requested for this event.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device and planning was not yet evaluated due to unclarity of the case.In case more information can be gained, a follow up will be made.

• 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: 17546104
• MDR Text Key: 321141723
• Report Number: 1222802-2023-00016
• 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: 08/14/2023

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: 08/10/2023
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: REF. 26401 4.8 PS X 8MM IMPLANT WITH THE 4.8MM