MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSPEED TX 4.5 - 11 MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number 24952

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); Pocket Erosion (2013)

Event Date 09/13/2022

Event Type  Injury  

Event Description

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

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.

Manufacturer Narrative

This is to add fda coding that was missed in the initial report.Adding additional health effect - clinical code -2013.Medical device problem code - 2017.Type of investigation code - 10.Investigation findings code - 3243.Investigation conclusions code - 61 correcting manufacturer narrative from: 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.To the correct narrative: therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.

• Brand Name: OSSEOSPEED TX 4.5 - 11 MM
• 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: 17349492
• MDR Text Key: 319285024
• Report Number: 3013111692-2023-49515
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07392532108242
• UDI-Public: 07392532108242
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K053384
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 24952
• Device Catalogue Number: 24952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/06/2023
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention