MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH IMPLANT DRIVER EXTENDER; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 68015197

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/14/2024

Event Type  Injury  

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.Product return is requested and product will be evaluated after receipt.

Event Description

In this event it is reported that implant drill extender came out and the patient swallowed the drill.Reportedly, the device was expelled out in the stool.An adverse form is being sent to the customer for completion.They are asking for a response to their complaint.

• Brand Name: IMPLANT DRIVER EXTENDER
• 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: 18959194
• MDR Text Key: 338359852
• Report Number: 3013111692-2024-08721
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 07392532266300
• UDI-Public: 07392532266300
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/22/2024

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: 68015197
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/11/2024
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: EV DRILL.
• Patient Outcome(s): Required Intervention