MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANK C/X IMPL A11/D3.5/L11; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 17-0544

Device Problems Improper or Incorrect Procedure or Method (2017); Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 06/26/2023

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.

Event Description

It was reported that a patient experienced a dental implant loss.

Manufacturer Narrative

This follow up report, is to correct this event to a non-reportable.This report was submitted in error.Please disregard the initial report.

• Brand Name: ANK C/X IMPL A11/D3.5/L11
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• 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: 17697462
• MDR Text Key: 322801696
• Report Number: 3013111692-2023-54649
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07392532206078
• UDI-Public: 07392532206078
• Combination Product (y/n): N
• Reporter Country Code: CB
• PMA/PMN Number: K140347
• 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,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 17-0544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/30/2023
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention