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

Catalog Number UNK ANKYLOS ABUTMENT

Device Problem Loss of Osseointegration (2408)

Patient Problem Failure of Implant (1924)

Event Date 05/11/2022

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 case is an implant removal due to abutment fracture.The catalog number and concomitant product had to be changed and the codes had to be revised.Remove codes: medical device problem code: 2408 add codes: medical device problem code: 1260.

• 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: 15111122
• MDR Text Key: 296655602
• Report Number: 3013111692-2022-14389
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK ANKYLOS ABUTMENT
• Device Lot Number: 20033059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/18/2022
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: ANK IMPL B11 D4,5 MM/L11 MM
• Patient Outcome(s): Required Intervention