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

Catalog Number UNK ANKYLOS ABUTMENT

Device Problem Fracture (1260)

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

Event Date 12/06/2021

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

The received implant is not broken, it was removed due to the fracture of the abutment.D1, d2, d4 and g4 corrected in this report.

• Brand Name: UNKNOWN ANKYLOS 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: 14285971
• MDR Text Key: 290770819
• Report Number: 3013111692-2022-06379
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: UNKNOWN
• 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: 07/08/2022

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: UNK ANKYLOS ABUTMENT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/27/2022
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention