MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH 3-STEP DRILL EV Ø2.5/3.1, 6-17; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 25168

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/13/2023

Event Type  Injury  

Event Description

A patient had 2 implants placed in the maxilla on thursday, (b)(6) 2023.During preparation in the anterior region, a drill extension from astra tech had to be used because the head of the contra-angle handpiece did not pass the neighboring teeth.When using the last drill (no.3 of the astra tech system), the drill came loose from the drill extension and fell towards the pharynx.Due to the swallowing reflex, the drill was swallowed by the patient.The patient was immediately informed of the situation.The dentist immediately contacted the (b)(6) institute dr.(b)(6), and subsequently gave a referral for the chest and abdominal x-ray.The patient went to the radiologist immediately after the procedure.The x-ray on thursday 13.07.Showed that the drill was in the digestive tract.The follow-up appointment was on (b)(6) 2023 with the radiologist.This x-ray showed that the drill was lodged in the appendix.The patient was sent directly to (b)(6) hospital by dr.(b)(6).The dentist was contacted by the surgeon from kh horn on (b)(6) 2023 and informed that a removal of the appendix was planned.This surgery took place on (b)(6) 2023.According to the surgeon, the appendix was not acute, but it was rather unlikely that the drill would advance from this position.The dentist had telephone contact with the patient on (b)(6) 2023.He reported that he felt well under the circumstances.He was discharged one day postoperatively on (b)(6) 2023.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.Product will not be returned due to the nature of the event.The return of the concomitant product 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: 3-STEP DRILL EV Ø2.5/3.1, 6-17
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17441983
• MDR Text Key: 320210455
• Report Number: 3013111692-2023-51012
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 08/02/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25168
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/01/2023
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/02/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 26021 IMPLANT DRIVER EXTENDER EV-GS.
• Patient Outcome(s): Required Intervention; Hospitalization