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 Erosion (1750); Failure of Implant (1924); Unspecified Infection (1930)

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

Implant loss due to mobility, infection, progressive bone loss.

Manufacturer Narrative

Brand name and catalog # were 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: 13712224
• MDR Text Key: 286876490
• Report Number: 3013111692-2022-00320
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• 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: 03/04/2022
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention