MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH UNKNOWN ATIS ABUTMENT; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number UNK ATIS ABUTMENT

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.Product was investigated.The fractured abutment screw surface was destroyed in an attempt to drill it out.No evaluation possible.Patient suffers of bruxism.Trend is tracked and monitored.

Event Description

Abutment fracture, implant loss.

• Brand Name: UNKNOWN ATIS ABUTMENT
• Type of Device: ABUTMENT, 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: 18566708
• MDR Text Key: 333515452
• Report Number: 3013111692-2024-02127
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 01/23/2024

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: UNK ATIS ABUTMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/04/2023
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: IMPLANT OSSEOSPEED TX 4.0SX11
• Patient Outcome(s): Required Intervention