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

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Lack of Effect (4065)

Patient Problem Failure of Implant (1924)

Event Date 01/25/2024

Event Type  Injury  

Event Description

In this event it is reported that surgiguide was used in an implant surgery.The guide fit well and reportedly, not issues during the surgery.It was found that the implant would spin.The implant was removed and bone grafting done.Doctor will wait a few months for this to heal and try the surgery again.New scans will be taken and new order placed for the surgiguide.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated, but the digital (guide) planning was, without having found any issues.

• 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: 18733815
• MDR Text Key: 335694117
• Report Number: 1222802-2024-00003
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/19/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/25/2024
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2024
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 26342 ASTRATECH IMPL EV 4.8S 9 MM