MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSPEED TX 3.5S - 11 MM; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 24932

Device Problem Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 09/06/2021

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

The brand name, catalog number and 510(k) have been corrected in this report.

• Brand Name: OSSEOSPEED TX 3.5S - 11 MM
• 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: 13949992
• MDR Text Key: 288192787
• Report Number: 3013111692-2022-02358
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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: 04/20/2022

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: 24932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/18/2022
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention