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

Catalog Number 37501

Device Problem Fracture (1260)

Patient Problem Laceration(s) (1946)

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

In this case a bone grafting was planned anyway.A small amount of buccal lamella was still present but was lost due to the fracture of the guide.Implant final position had to be slightly adjusted and a more comprehensive augmentation had to be done.In the end it was possible to complete the surgery.Product return is requested, and product and case will be evaluated after receipt.A follow-up report will be sent once results are available.Trend is tracked and monitored.

Event Description

Surgiguide broken during surgery.Buccal bone lamella fractured.It went wrong during the second drilling step, so drill 3.Then the guide broke, and the drill knocked away the buccal wall.Jaw itself is not broken.Implantologist then decided to continue manually and placed the implant further palatal to find primary stability and placed cover screw.He had also to do quite a bit of bone building to resolve the defect.The implantologist then made an etching bridge to send the patient home with care.So, he was able to solve it.Bone grafting was planned during surgery, but there was still a small amount of buccal lamella present, but this has been lost.

• 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: 18273966
• MDR Text Key: 329830422
• Report Number: 3007362683-2023-00043
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 37501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/21/2023
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention