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

Catalog Number UNK ATIS EV ABUTMENT

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pocket Erosion (2013)

Event Date 09/06/2022

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.

Event Description

It was reported that a patient experienced a dental implant loss.

Manufacturer Narrative

The optical investigation showed that the implant is not fractured but was removed due to the fracture of a screw or one-piece abutment.Corrected product information, lot number and concomitant product in this report.This report is to also correct the following codes: component code: add 568; type of investigation: add 10 and 4116; investigation findings: remove 3243.

• Brand Name: UNKNOWN ATIS EV 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: 15637971
• MDR Text Key: 302057133
• Report Number: 3013111692-2022-21692
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK ATIS EV ABUTMENT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/17/2022
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: OSSEOSPEED EV 4.8 S - 9 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female