MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE - 2 IMPLANTS; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/30/2023

Event Type  Injury  

Event Description

The guide fractured in distal of tooth 43 during its positioning in order to begin the drilling.Immediate intraoperative repair was not possible as the guide was fractured again, but elsewhere in the repair, at site 45.The surgeon stopped the surgery.The fit of the guide was checked in patient's mouth before surgery.The patient was already sedated.An incision on the site of patient's mouth has been made.The customer could not start the drilling.At the end, the patient received a prescription for antibiotics, a local antiseptic mouth wash and a pain killer.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.

• Brand Name: SURGIGUIDE - 2 IMPLANTS
• 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: 16451717
• MDR Text Key: 310325707
• Report Number: 3007362683-2023-00027
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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: 02/07/2023
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention