MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSPEED TX 4.0S - 9 MM; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 24941

Device Problem Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Date 04/30/2020

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

Correction udi # from udi # (b)(4) to udi # (b)(4).Correction product code from ndp to dze.Device received for this event is being corrected from impl pick-up 3.5/4.0 short catalog # 24947 to osseospeed tx 4.0s - 9 mm catalog # 24941.This is a follow up report to correct this information.

• Brand Name: OSSEOSPEED TX 4.0S - 9 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: 17547971
• MDR Text Key: 321135220
• Report Number: 3013111692-2023-52537
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 07392532108303
• UDI-Public: 07392532108303
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/08/2023

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: 24941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/12/2023
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention